Notified Body
NB 2797
🇳🇱 Netherlands
BSI Group The Netherlands B.V.
Say Building, John M. Keynesplein 9, 1066 EP, Amsterdam, Netherlands
View on EUDAMED
Updated Nov 16, 2024
Certificates
376
Valid
0
Expiring < 6mo
0
Expired
339
Basic UDI-DIs
26587
Devices
26564
Manufacturers
192
Cert. Types
11
Basic Information
- Address
- Say Building, John M. Keynesplein 9, 1066 EP, Amsterdam, Netherlands
- [email protected] (medical devices, IVDs); [email protected] (all other legislations)
- Phone
- +31 (0)20 346 07 80
- Website
- www.bsigroup.com
Regulatory Overview
Regulation
Loading...
Eu Mdd
26257
Eu Ivdd
173
Eu Aimdd
157
Classification
Loading...
Eu Md Class 2b
14195
Eu Md Class 3
6190
Eu Md Class 2a
5720
Eu Aimdd Class
157
Eu Md Class 1
152
Eu Ivd General
71
Eu Ivd Annex 2 List B
69
Eu Ivd Annex 2 List A
27
Eu Ivd Self Testing
6
Device Types
Loading...
Certificate Health
Total
376
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
339
Certificates by Expiry Year
Loading...
| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| MDD Annex II (excluding section 4) | CE666288 | i+Med S.Coop. | Feb 03, 2020 | |||
| MDD Annex II Section 4 | CE648854 | CeloNova BioSciences, Inc. | Jul 18, 2021 | |||
| MDD Annex II Section 4 | CE648854 | CeloNova BioSciences, Inc. | Jul 18, 2021 | |||
| MDD Annex V | 687569 | Chalice Medical Ltd | Aug 03, 2021 | |||
| MDD Annex II Section 4 | CE 687568 | Chalice Medical Ltd | Aug 03, 2021 | |||
| MDD Annex II (excluding section 4) | 636429 | SYSTHEX - SISTEMAS DE IMPLANTES OSSEO INTEGRADO LTDA | Aug 10, 2021 | |||
| MDD Annex II (excluding section 4) | CE 576090 | orangedental GmbH & Co. KG | Sep 25, 2021 | |||
| MDD Annex II Section 4 | CE 661862 | Spectranetics Corporation | Nov 20, 2021 | |||
| MDD Annex II (excluding section 4) | 663771 | exocad GmbH | Feb 25, 2022 | |||
| MDD Annex II Section 4 | CE 579514 | Spectranetics Corporation | Feb 28, 2022 | |||
| MDD Annex II (excluding section 4) | CE 579513 | Spectranetics Corporation | Feb 28, 2022 | |||
| MDD Annex II (excluding section 4) | 6774 | Perspectum Ltd | Mar 01, 2022 | |||
| MDD Annex II (excluding section 4) | 677486 | Perspectum Ltd | Mar 01, 2022 | |||
| MDD Annex II (excluding section 4) | Mevion S250i | Mevion Medical Systems, Inc. | Mar 07, 2022 | |||
| MDD Annex II (excluding section 4) | CE 714517 | ADAS3D MEDICAL, S.L. | Mar 09, 2022 | |||
| MDD Annex II Section 4 | 571289 | Inion Oy | Mar 30, 2022 | |||
| MDD Annex II Section 4 | 571260 | Inion Oy | Mar 30, 2022 | |||
| MDD Annex II Section 4 | 571286 | Inion Oy | Mar 31, 2022 | |||
| MDD Annex II (excluding section 4) | CE 647943 | Inovytec Medical Solutions Ltd. | Jun 11, 2022 | |||
| MDD Annex II (excluding section 4) | CE663289 | Qynapse | Jun 29, 2022 | |||
| MDD Annex II (excluding section 4) | CE 663351 | EDL (Edition et Développement de Logiciels) | Aug 02, 2022 | |||
| MDD Annex II (excluding section 4) | CE663351 | EDL (Edition et Développement de Logiciels) | Aug 02, 2022 | |||
| MDD Annex II Section 4 | CE 742557 | Volcano Corporation | Aug 15, 2022 | |||
| MDD Annex II Section 4 | 670605 | Infraredx, Inc. | Aug 24, 2022 | |||
| MDD Annex II (excluding section 4) | 684866 | OrthoXel DAC | Sep 10, 2022 | |||
| MDD Annex II (excluding section 4) | CE 684866 | OrthoXel DAC | Sep 10, 2022 | |||
| IVDD Annex IV (excluding sections 4, 6) | 668398 | Beckman Coulter Inc. | Sep 14, 2022 | |||
| MDD Annex II Section 4 | CE 623392 | Dongguan Kewei Medical Instrument Co., Ltd. | Sep 21, 2022 | |||
| MDD Annex II Section 4 | 644319 | Orthocell Ltd | Oct 11, 2022 | |||
| MDD Annex II Section 4 | 571292 | Inion Oy | Oct 21, 2022 | |||
| MDD Annex II (excluding section 4) | 525912 | SURETEX LIMITED | Nov 21, 2022 | |||
| MDD Annex II (excluding section 4) | CE525912 | SURETEX LIMITED | Nov 22, 2022 | |||
| MDD Annex II (excluding section 4) | CE 673195 | Cortex Dental Implants Industries Ltd. | Nov 30, 2022 | |||
| MDD Annex II Section 4 | 667794 | Inion Oy | Dec 11, 2022 | |||
| MDD Annex II Section 4 | CE 623391 | Dongguan Kewei Medical Instrument Co., Ltd. | Dec 18, 2022 | |||
| MDD Annex II (excluding section 4) | CE651388 | CeloNova BioSciences, Inc. | Dec 19, 2022 | |||
| MDD Annex II (excluding section 4) | CE651388 | CeloNova BioSciences, Inc. | Dec 19, 2022 | |||
| MDD Annex II Section 4 | CE 634229 | Spectranetics Corporation | Dec 30, 2022 | |||
| MDD Annex II Section 4 | 583404 | DSM Biomedical | Jan 01, 2023 | |||
| MDD Annex II Section 4 | 686790 | DSM Biomedical | Jan 01, 2023 | |||
| MDD Annex II (excluding section 4) | CE 701724 | Young Innovations Inc | Jan 13, 2023 | |||
| MDD Annex II (excluding section 4) | 654972 | SUBLIMED | Jan 22, 2023 | |||
| MDD Annex V | 681889 | Mosaic Surgical Ltd | Feb 26, 2023 | |||
| MDD Annex II (excluding section 4) | CE886621 | Surgical Innovations Ltd. | Mar 18, 2023 | |||
| MDD Annex II (excluding section 4) | CE 01874 | Bicon, LLC | Mar 31, 2023 | |||
| MDD Annex II (excluding section 4) | CE 19995 | OrbusNeich Medical, B.V. | Apr 21, 2023 | |||
| MDD Annex II (excluding section 4) | CE 619995 | OrbusNeich Medical, B.V. | Apr 21, 2023 | |||
| MDD Annex II Section 4 | 571290 | Inion Oy | Apr 24, 2023 | |||
| MDD Annex II Section 4 | 571291 | Inion Oy | Apr 24, 2023 | |||
| MDD Annex II (excluding section 4) | CE 664546 | Medical-Latex (DUA) Sdn. Bhd. | Apr 25, 2023 | |||
| MDD Annex II (excluding section 4) | T54BH-N4 | Medical-Latex (DUA) Sdn. Bhd. | Apr 25, 2023 | |||
| MDD Annex V | 632124 | Surgilum, LLC | May 26, 2023 | |||
| MDD Annex II Section 4 | CE 649479 | OrbusNeich Medical, B.V. | May 26, 2023 | |||
| MDD Annex II (excluding section 4) | CE683210 | Blink Device Company | May 30, 2023 | |||
| MDD Annex II (excluding section 4) | 676122 | Checkpoint Surgical, Inc. | Jun 06, 2023 | |||
| MDD Annex II (excluding section 4) | CE 676122 | Checkpoint Surgical, Inc. | Jun 06, 2023 | |||
| MDD Annex II Section 4 | CE 649480 | OrbusNeich Medical, B.V. | Jun 15, 2023 | |||
| MDD Annex II (excluding section 4) | CE 598352 | Zest Anchors, LLC | Jun 18, 2023 | |||
| MDD Annex II (excluding section 4) | CE596712 | Heraeus Medical Components LLC | Jun 27, 2023 | |||
| MDD Annex II Section 4 | CE596713 | Heraeus Medical Components LLC | Jun 27, 2023 | |||
| MDD Annex II Section 4 | 571287 | Inion Oy | Jun 29, 2023 | |||
| MDD Annex V | 571257 | Inion Oy | Jun 29, 2023 | |||
| MDD Annex II (excluding section 4) | 571256 | Inion Oy | Jun 29, 2023 | |||
| MDD Annex II (excluding section 4) | 01801 | Lenstec (Barbados) Inc. | Jul 06, 2023 | |||
| MDD Annex II (excluding section 4) | 01081 | Lenstec (Barbados) Inc. | Jul 06, 2023 | |||
| MDD Annex II (excluding section 4) | Softec HD3™ | Lenstec (Barbados) Inc. | Jul 06, 2023 | |||
| MDD Annex II (excluding section 4) | SBL-3™ | Lenstec (Barbados) Inc. | Jul 06, 2023 | |||
| MDD Annex II (excluding section 4) | CE 597920 | Yukon Medical, LLC | Jul 20, 2023 | |||
| MDD Annex II (excluding section 4) | CE 597920 | Yukon Medical, LLC | Jul 20, 2023 | |||
| MDD Annex II Section 4 | 597638 | Allergan Sales, LLC | Aug 05, 2023 | |||
| MDD Annex V | CE 675412 | Advanced Echo Technology | Aug 07, 2023 | |||
| MDD Annex II (excluding section 4) | CE660601 | Implantica CE Reflux Ltd. | Aug 07, 2023 | |||
| MDD Annex V | CE589950 | FORTUNE MEDICAL INSTRUMENT CORP. | Sep 24, 2023 | |||
| MDD Annex II (excluding section 4) | CE588902 | FORTUNE MEDICAL INSTRUMENT CORP. | Sep 24, 2023 | |||
| MDD Annex II Section 4 | CE 743219 | Cook Biotech Incorporated | Sep 27, 2023 | |||
| MDD Annex II (excluding section 4) | CE 689414 | Flat Medical Co., Ltd. | Oct 08, 2023 | |||
| MDD Annex V | CE 686509 | Contract Medical Manufacturing | Oct 10, 2023 | |||
| MDD Annex II (excluding section 4) | 662942 | BNOS MediTECH | Oct 19, 2023 | |||
| MDD Annex II (excluding section 4) | 662942 | BNOS MediTECH | Oct 19, 2023 | |||
| MDD Annex II Section 4 | CE 663700 | BrosMed Medical Co., Ltd | Oct 19, 2023 | |||
| MDD Annex II Section 4 | CE 663700 | BrosMed Medical Co., Ltd | Oct 19, 2023 | |||
| MDD Annex II Section 4 | CE 663704 | BrosMed Medical Co., Ltd | Oct 20, 2023 | |||
| MDD Annex II (excluding section 4) | CE618251 | Med-Logics, Inc. | Nov 01, 2023 | |||
| MDD Annex II Section 4 | 645522 | EUROSILICONE SAS | Nov 09, 2023 | |||
| MDD Annex II Section 4 | CE 645522 | EUROSILICONE SAS | Nov 09, 2023 | |||
| MDD Annex II (excluding section 4) | 645522 | EUROSILICONE SAS | Nov 10, 2023 | |||
| MDD Annex V | CE 603028 | Thornton & Ross Ltd | Nov 22, 2023 | |||
| MDD Annex V | CE603028 | Thornton & Ross Ltd | Nov 22, 2023 | |||
| MDD Annex II (excluding section 4) | CE 543428 | Research and Production Company «Monitor» Limited | Nov 26, 2023 | |||
| MDD Annex II (excluding section 4) | CE 539277 | Circle Cardiovascular Imaging Inc | Nov 27, 2023 | |||
| MDD Annex II Section 4 | CE 652872 | Regen Lab SA | Nov 28, 2023 | |||
| MDD Annex II (excluding section 4) | 684406 | Synopsys (Northern Europe) Ltd | Dec 10, 2023 | |||
| MDD Annex III | 646245 | Actegy Limited | Dec 23, 2023 | |||
| MDD Annex II (excluding section 4) | 00458 | Xiros Limited | Jan 10, 2024 | |||
| MDD Annex II (excluding section 4) | CE 685410 | Aeon Biotherapeutics Corp. | Jan 14, 2024 | |||
| IVDD Annex VI | MD 724530 | Diagnotix B.V. | Feb 02, 2024 | |||
| MDD Annex II (excluding section 4) | CE603008 | ChipSoft | Feb 04, 2024 | |||
| MDD Annex V | CE694938 | Kesem Health Pty Ltd | Feb 13, 2024 | |||
| MDD Annex II (excluding section 4) | CE 690387 | ROBOCATH S.A.S | Feb 17, 2024 | |||
| MDD Annex II (excluding section 4) | 679656 | Japet Medical Devices | Feb 19, 2024 | |||
| MDD Annex II (excluding section 4) | CE 649483 | OrbusNeich Medical (Shenzhen) Co.,Ltd | Feb 19, 2024 | |||
| MDD Annex II (excluding section 4) | CE595246 | QXMedical, LLC | Mar 04, 2024 | |||
| MDD Annex V | CE 684773 | eXroid Technology Ltd | Mar 05, 2024 | |||
| MDD Annex V | 684773 | eXroid Technology Ltd | Mar 05, 2024 | |||
| MDD Annex II Section 4 | 654813 | ImpediMed Limited | Mar 10, 2024 | |||
| MDD Annex II Section 4 | CE654813 | ImpediMed Limited | Mar 10, 2024 | |||
| MDD Annex II (excluding section 4) | CE 695793 | Advanced Medical Solutions Ltd | Mar 20, 2024 | |||
| MDD Annex II Section 4 | CE 611537 | Spectranetics Corporation | Mar 24, 2024 | |||
| MDD Annex II Section 4 | 612851 | Nagor Limited | Mar 25, 2024 | |||
| MDD Annex II Section 4 | 612851 | Nagor Limited | Mar 25, 2024 | |||
| MDD Annex II Section 4 | 612851 | Nagor Limited | Mar 25, 2024 | |||
| MDD Annex II Section 4 | CE 686786 | Butterfly Network, Inc. | Mar 31, 2024 | |||
| MDD Annex II Section 4 | CE 707910 | Bicon, LLC | Mar 31, 2024 | |||
| MDD Annex II (excluding section 4) | 02248 | Nagor Limited | Apr 01, 2024 | |||
| MDD Annex II (excluding section 4) | 02284 | Nagor Limited | Apr 01, 2024 | |||
| MDD Annex II (excluding section 4) | CE 704941 | Theraclion | Apr 07, 2024 | |||
| MDD Annex II (excluding section 4) | CE 544967 | Tristel Solutions Limited | Apr 19, 2024 | |||
| IVDD Annex IV (excluding sections 4, 6) | CE 737648 | PathoFinder B.V. | May 01, 2024 | |||
| MDD Annex II (excluding section 4) | CE 673331 | Flow Neuroscience AB | May 05, 2024 | |||
| MDD Annex II (excluding section 4) | 01082 | The Magstim Company Limited | May 05, 2024 | |||
| MDD Annex II Section 4 | CE 611679 | Spectranetics Corporation | May 11, 2024 | |||
| MDD Annex II (excluding section 4) | CE 679435 | Maltron International Ltd | May 12, 2024 | |||
| IVDD Annex IV (excluding sections 4, 6) | CE 572691 | LGC Clinical Diagnostics, Inc. | May 12, 2024 | |||
| MDD Annex II (excluding section 4) | CE 699755 | Vortex Surgical Inc | May 19, 2024 | |||
| MDD Annex II (excluding section 4) | 571753 | ElectroCore, Inc. | May 24, 2024 | |||
| MDD Annex II (excluding section 4) | 2797 | ElectroCore, Inc. | May 24, 2024 | |||
| AIMDD Annex II Section 4 | CE576072 | Mainstay Medical Limited | May 24, 2024 | |||
| MDD Annex II (excluding section 4) | CE 620265 | BrosMed Medical Co., Ltd | May 25, 2024 | |||
| MDD Annex II (excluding section 4) | 612985 | Insulet Corporation | May 25, 2024 | |||
| MDD Annex II Section 4 | 595697 | Bioglan AB | May 25, 2024 | |||
| MDD Annex II (excluding section 4) | 691963 | Silverfox Corporation Limited | May 25, 2024 | |||
| MDD Annex II (excluding section 4) | 685187 | MJN Neuroserveis S.L. | May 25, 2024 | |||
| MDD Annex II (excluding section 4) | 645455 | EUROSILICONE SAS | May 25, 2024 | |||
| MDD Annex II (excluding section 4) | 612985 | Insulet Corporation | May 25, 2024 | |||
| MDD Annex II Section 4 | CE 620000 | OrbusNeich Medical, B.V. | May 25, 2024 | |||
| MDD Annex II (excluding section 4) | CE 612985 | Insulet Corporation | May 25, 2024 | |||
| MDD Annex II (excluding section 4) | CE 669612 | Euromi Biosciences | May 25, 2024 | |||
| MDD Annex II Section 4 | CE 669619 | Euromi Biosciences | May 25, 2024 | |||
| MDD Annex II Section 4 | CE 712118 | OrbusNeich Medical, B.V. | May 25, 2024 | |||
| MDD Annex II (excluding section 4) | 635333 | AventaMed DAC | May 25, 2024 | |||
| MDD Annex II Section 4 | CE 706144 | OrbusNeich Medical, B.V. | May 25, 2024 | |||
| MDD Annex II (excluding section 4) | CE674184 | EUROMI | May 25, 2024 | |||
| MDD Annex II Section 4 | CE 706144 | OrbusNeich Medical, B.V. | May 25, 2024 | |||
| MDD Annex II (excluding section 4) | CE 674184 | EUROMI | May 25, 2024 | |||
| MDD Annex II (excluding section 4) | CE 705664 | Suzhou RainMed Medical Technology Co., Ltd. | May 25, 2024 | |||
| MDD Annex II (excluding section 4) | CE 705664 | Suzhou RainMed Medical Technology Co., Ltd. | May 25, 2024 | |||
| MDD Annex V | CE 577120 | Joint Stock Company "Ryazan State Instrument-making Enterprise" | May 25, 2024 | |||
| MDD Annex II (excluding section 4) | HD 2054277-1 | BrosMed Medical Co., Ltd | May 25, 2024 | |||
| MDD Annex II (excluding section 4) | CE647488 | Cardiologs Technologies | May 25, 2024 | |||
| MDD Annex II (excluding section 4) | CE 620265 | BrosMed Medical Co., Ltd | May 25, 2024 | |||
| MDD Annex II (excluding section 4) | CE 620265 2024-05-26 | BrosMed Medical Co., Ltd | May 25, 2024 | |||
| MDD Annex II (excluding section 4) | CE 620265 | BrosMed Medical Co., Ltd | May 25, 2024 | |||
| MDD Annex II (excluding section 4) | C010402020101 | BrosMed Medical Co., Ltd | May 25, 2024 | |||
| MDD Annex II Section 4 | CE 632474 | Spectranetics Corporation | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | M.2020.106.13150 | BrosMed Medical Co., Ltd | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | M.2020.106.13150 | BrosMed Medical Co., Ltd | May 26, 2024 | |||
| AIMDD Annex II Section 4 | 559663 | ZOLL Respicardia, Inc. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | CE 705577 | Ambulanc(Shenzhen)Tech.Co., Ltd. | May 26, 2024 | |||
| MDD Annex II Section 4 | CE711684 | NovaCutis GmbH | May 26, 2024 | |||
| MDD Annex II Section 4 | CE 711684 | NovaCutis GmbH | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | CE 550209 | Spectranetics Corporation | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | CE 634290 | Philips Medical Systems Nederland B.V. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 607775 | Aseptico, Inc. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | CE01082 | The Magstim Company Limited | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | CE 621167 | Intact Vascular, Inc. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | CE 562232 | Broncus Medical, Inc. | May 26, 2024 | |||
| MDD Annex II Section 4 | CE 742147 | Volcano Corporation | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 637897 | AST VisionCare Inc. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | CE 742145 | Volcano Corporation | May 26, 2024 | |||
| MDD Annex II Section 4 | CE 742150 | Volcano Corporation | May 26, 2024 | |||
| MDD Annex II Section 4 | CE691616 | Evolan Pharma AB | May 26, 2024 | |||
| MDD Annex II Section 4 | CE 742146 | Volcano Corporation | May 26, 2024 | |||
| MDD Annex II Section 4 | CE691617 | Evolan Pharma AB | May 26, 2024 | |||
| MDD Annex II Section 4 | CE 554849 | Spectranetics Corporation | May 26, 2024 | |||
| MDD Annex II Section 4 | CE 742149 | Volcano Corporation | May 26, 2024 | |||
| AIMDD Annex II Section 4 | 653955 | Saluda Medical Pty Ltd | May 26, 2024 | |||
| AIMDD Annex II Section 4 | 653955 | Saluda Medical Pty Ltd | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 573469 | Creo Medical | May 26, 2024 | |||
| MDD Annex II Section 4 | CE 554813 | Spectranetics Corporation | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | CE551576 | Philips India Limited | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | CE 632473 | Spectranetics Corporation | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 674184 | EUROMI | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | CE6422227 | Argon Medical Production & Vertriebs Gesellschaft mbH & Co. KG | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | CVE6422227 | Argon Medical Production & Vertriebs Gesellschaft mbH & Co. KG | May 26, 2024 | |||
| MDD Annex II Section 4 | CE 735820 | Volcano Corporation | May 26, 2024 | |||
| MDD Annex II Section 4 | CE 650647 | Spectranetics Corporation | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | CE697225 | ENDRA Life Sciences, Inc. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | CE642227 | Argon Medical Production & Vertriebs Gesellschaft mbH & Co. KG | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | Ce6422227 | Argon Medical Production & Vertriebs Gesellschaft mbH & Co. KG | May 26, 2024 | |||
| MDD Annex V | CE 687569 | Chalice Medical Ltd | May 26, 2024 | |||
| MDD Annex V | 615075 | ElectroCore, Inc. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | CE 678945 | Uptake Medical B.V. | May 26, 2024 | |||
| MDD Annex V | CE697659 | Shenzhen AsTec Technology Co., Ltd | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | CE 735600 | Turner Imaging Systems, Inc. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | CS6422227 | Argon Medical Production & Vertriebs Gesellschaft mbH & Co. KG | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | CE 506973 | Aktina Medical Corp | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | CE 549032 | HAKKO CO., LTD. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | CE 601642 | Profound Medical Inc. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 614372 | Serb Medical Solutions Inc. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | CE 749991 | Precision Medical Ventures Inc. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | CE683722 | Breas Medical AB | May 26, 2024 | |||
| MDD Annex II Section 4 | 552477 | DSM Biomedical | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 601642 | Profound Medical Inc. | May 26, 2024 | |||
| MDD Annex II Section 4 | 552587 | DSM Biomedical | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | CE 689660 | CSA Medical | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 577532 | ReCor Medical, Inc. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 670602 | Infraredx, Inc. | May 26, 2024 | |||
| IVDD Annex IV (excluding sections 4, 6) | CE635228 | RECIPE Chemicals + Instruments GmbH | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | CE 709972 | Medtrum Technologies Inc. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | CE 637897 | AST VisionCare Inc. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 643911 | Innovate Orthopaedics | May 26, 2024 | |||
| MDD Annex II Section 4 | 698954 | Dentscare Ltda | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | CE593638 | Nuraleve | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 632901 | DELEO S.A.S. | May 26, 2024 | |||
| IVDD Annex IV (excluding sections 4, 6) | CE614409 | iXensor Co., Ltd. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | CE556743 | Breas Medical Limited | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | CE 598543 | Bracco Injeneering SA | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | CE 603229 | Biobot Surgical Pte Ltd | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | CE 53165 | Tecnilatex, S.A.U. | May 26, 2024 | |||
| MDD Annex II Section 4 | CE666920 | i+Med S.Coop. | May 26, 2024 | |||
| MDD Annex II Section 4 | CE-666290 | i+Med S.Coop. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 611434 | Combe Incorporated | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | CE 648468 | Combat Medical Ltd | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | CE-701506 | TTK HEALTHCARE LIMITED - PROTECTIVE DEVICES DIVISION | May 26, 2024 | |||
| MDD Annex V | CE 556174 | CorneaGen | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 614372 | Serb Medical Solutions Inc. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | CE 94777 | Submarine Manufacturing & Products Ltd | May 26, 2024 | |||
| MDD Annex II Section 4 | 558748 | DSM Biomedical | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | CE 620880 | Karex Industries Sdn. Bhd. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 600283 | USGI Medical | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 617759 | Pacific Consolidated Industries LLC | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | CE 700456 | Wuhan Dimed Laser Technology Co., Ltd. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | CE 617759 | Pacific Consolidated Industries LLC | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | CE 591560 | Dexcom | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | CE 709431 | Dynamic Metrics Limited | May 26, 2024 | |||
| MDD Annex V | CE98427 | Kobayashi Healthcare Europe Limited | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | CE 597147 | Opsens Inc. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | CE 641606 | Rad Source Technologies Inc. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | CE 652481 | Coala Life AB | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | CE652481 | Coala Life AB | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | CE 673550 | Radley Scientific Ltd | May 26, 2024 | |||
| IVDD Annex IV (excluding sections 4, 6) | CE 572693 | LGC Clinical Diagnostics, Inc. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | CE 597148 | Opsens Inc. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 663778 | Volpara Health Technologies Limited | May 26, 2024 | |||
| MDD Annex II Section 4 | CE 652693 | Gelesis Srl | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | CE 642989 | Regen Lab SA | May 26, 2024 | |||
| MDD Annex II Section 4 | CE 652871 | Regen Lab SA | May 26, 2024 | |||
| MDD Annex II Section 4 | CE 684926 | Wallaby Medical | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | CE 684927 | Wallaby Medical | May 26, 2024 | |||
| MDD Annex II Section 4 | CE611677 | Lifetech Scientific (Shenzhen) Co., Ltd. | May 26, 2024 | |||
| MDD Annex II Section 4 | 633491 | Nagor Limited | May 26, 2024 | |||
| MDD Annex II Section 4 | 633491 | Nagor Limited | May 26, 2024 | |||
| MDD Annex II Section 4 | 633491 | Nagor Limited | May 26, 2024 | |||
| MDD Annex V | 623697 | Vitame Ltd | May 26, 2024 | |||
| MDD Annex V | CE 623697 | Vitame Ltd | May 26, 2024 | |||
| MDD Annex II Section 4 | 633491 | Nagor Limited | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | CE 545606 | NEUROWAVE SYSTEMS, INC. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | CE 698635 | Shenzhen Lifetech Cardio Medical Electronics Co.,Ltd. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | CE 703694 | Vyaire Medical, Inc. | May 26, 2024 | |||
| MDD Annex V | CE01981 | Young Dental Manufacturing I, LLC | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | CE 556743 | Breas Medical Limited | May 26, 2024 | |||
| IVDD Annex IV (excluding sections 4, 6) | CE 614409 | iXensor Co., Ltd. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | CE 643878 | Medprin Regenerative Medical Technologies Co., Ltd. | May 26, 2024 | |||
| MDD Annex II Section 4 | CE 613931 | Medprin Regenerative Medical Technologies Co., Ltd. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | CE 613930 | Medprin Regenerative Medical Technologies Co., Ltd. | May 26, 2024 | |||
| MDD Annex II Section 4 | CE 620362 | Medprin Regenerative Medical Technologies Co., Ltd. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | CE 656054 | Channel Medsystems, Inc. | May 26, 2024 | |||
| MDD Annex II Section 4 | CE 667433 | Medprin Regenerative Medical Technologies Co., Ltd. | May 26, 2024 | |||
| MDD Annex II Section 4 | CE 633491 | Nagor Limited | May 26, 2024 | |||
| MDD Annex II Section 4 | CE 719612 | Nagor Limited | May 26, 2024 | |||
| MDD Annex II Section 4 | CE 719612 | Nagor Limited | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | CE 84733 | Philips Medical Systems (Cleveland), Inc. | May 26, 2024 | |||
| MDD Annex II Section 4 | CE 630631 | NovaBone Products, LLC | May 26, 2024 | |||
| MDD Annex II Section 4 | CE 630624 | NovaBone Products, LLC | May 26, 2024 | |||
| MDD Annex II Section 4 | CE630624 | NovaBone Products, LLC | May 26, 2024 | |||
| MDD Annex II Section 4 | CE 630627 | NovaBone Products, LLC | May 26, 2024 | |||
| MDD Annex II Section 4 | CE 630625 | NovaBone Products, LLC | May 26, 2024 | |||
| MDD Annex II Section 4 | CE 667434 | Medprin Regenerative Medical Technologies Co., Ltd. | May 26, 2024 | |||
| MDD Annex V | 81758 | Northern Digital Inc. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | CE 621938 | Medprin Biotech GmbH | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | CE 703557 | Infervision Medical Technology Co., Ltd. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | CE 613049 | Dongguan Kewei Medical Instrument Co., Ltd. | May 26, 2024 | |||
| MDD Annex II Section 4 | CE 677889 | Dongguan Kewei Medical Instrument Co., Ltd. | May 26, 2024 | |||
| MDD Annex II Section 4 | CE 677886 | Dongguan Kewei Medical Instrument Co., Ltd. | May 26, 2024 | |||
| MDD Annex II Section 4 | CE 621939 | Medprin Biotech GmbH | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | CE 619280 | Medprin Biotech GmbH | May 26, 2024 | |||
| MDD Annex II Section 4 | CE 619285 | Medprin Biotech GmbH | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | CE612569 | Intelerad Medical Systems Incorporated | May 26, 2024 | |||
| MDD Annex V | 01958 | Ribbond, Inc. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | CE 699509 | New NI Medical (2011) Ltd. | May 26, 2024 | |||
| MDD Annex II Section 4 | CE 673071 | OrbusNeich Medical, B.V. | May 26, 2024 | |||
| MDD Annex II Section 4 | CE 649589 | OrbusNeich Medical, B.V. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | CE 698580 | CamDiab | May 26, 2024 | |||
| AIMDD Annex II Section 4 | 691392 | Zhejiang Nurotron Biotechnology Co., Ltd. | May 26, 2024 | |||
| AIMDD Annex II Section 4 | Enduro Earhook | Zhejiang Nurotron Biotechnology Co., Ltd. | May 26, 2024 | |||
| MDD Annex II Section 4 | CE571156 | Corvia Medical, Inc. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | CE 619401 | BRACCO SUISSE SA | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 612985 | Insulet Corporation | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 643100 | NOxBOX Limited | May 26, 2024 | |||
| MDD Annex VI | CE 552177 | Dr. Kleine Pharma GmbH | May 26, 2024 | |||
| MDD Annex II Section 4 | CE 650182 | Prytime Medical Devices Inc. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | CE 650126 | Prytime Medical Devices Inc. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | CE 556743 | Breas Medical Limited | May 26, 2024 | |||
| MDD Annex II Section 4 | CE 646780 | OrbusNeich Medical, B.V. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | CE 674683 | Sports Art Industrial Co., Ltd. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | CE 651490 | Micropace Pty Ltd | May 26, 2024 | |||
| MDD Annex II Section 4 | CE 743215 | Cook Biotech Incorporated | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | CE704048 | Brain Navi Biotechnology Co., Ltd. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 523004 | Accuray Incorporated | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | CE 641110 | Cook BioDevice | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | CE 706141 | OrbusNeich Medical (Shenzhen) Co.,Ltd | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | CE 649487 | OrbusNeich Medical (Shenzhen) Co.,Ltd | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | CE 712825 | OrbusNeich Medical (Shenzhen) Co.,Ltd | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | CE 646778 | OrbusNeich Medical (Shenzhen) Co.,Ltd | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | CE 619994 | OrbusNeich Medical (Shenzhen) Co.,Ltd | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | E 649487 | OrbusNeich Medical (Shenzhen) Co.,Ltd | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | CE 738308 | Tasso, Inc. | May 26, 2024 | |||
| MDD Annex II Section 4 | CE684868 | QXMedical, LLC | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | FM 703204 | LifeGlobal Group, LLC | Feb 19, 2025 | |||
| IVDD Annex IV Section 4 | CE726465 | GENOTROPY | May 26, 2025 | |||
| IVDD Annex IV (excluding sections 4, 6) | CE726461 | GENOTROPY | May 26, 2025 | |||
| IVDD Annex IV (excluding sections 4, 6) | CE 588493 | Blackhills Diagnostic Resources S.L.U. | May 26, 2025 | |||
| IVDD Annex IV (excluding sections 4, 6) | 575325 | LGC Clinical Diagnostics, Inc. | May 26, 2025 | |||
| IVDD Annex IV (excluding sections 4, 6) | CE 575325 | LGC Clinical Diagnostics, Inc. | May 26, 2025 | |||
| IVDD Annex IV (excluding sections 4, 6) | CE 694131 | Omixon Biocomputing Ltd. | May 26, 2025 | |||
| IVDD Annex IV (excluding sections 4, 6) | CE 694131 | Omixon Biocomputing Ltd. | May 26, 2025 | |||
| IVDD Annex IV (excluding sections 4, 6) | CE 572685 | LGC Clinical Diagnostics, Inc. | May 26, 2025 | |||
| IVDD Annex IV (excluding sections 4, 6) | CE 572694 | LGC Clinical Diagnostics, Inc. | May 26, 2025 | |||
| IVDD Annex IV (excluding sections 4, 6) | CE 572689 | LGC Clinical Diagnostics, Inc. | May 26, 2025 | |||
| IVDD Annex IV (excluding sections 4, 6) | CE 572688 | LGC Clinical Diagnostics, Inc. | May 26, 2025 | |||
| IVDD Annex IV (excluding sections 4, 6) | CE 572687 | LGC Clinical Diagnostics, Inc. | May 26, 2025 | |||
| IVDD Annex IV (excluding sections 4, 6) | CE 572692 | LGC Clinical Diagnostics, Inc. | May 26, 2025 | |||
| IVDD Annex IV (excluding sections 4, 6) | CE 732232 | Logical Medical Systems Limited | May 26, 2025 | |||
| IVDD Annex IV Section 4 | 765852 | Beckman Coulter Inc. | May 26, 2025 | |||
| IVDD Annex IV Section 4 | 716015 | Atomo Diagnostics Limited | May 26, 2025 | |||
| IVDD Annex IV (excluding sections 4, 6) | 637070 | Atomo Diagnostics Limited | May 26, 2025 | |||
| IVDD Annex IV (excluding sections 4, 6) | CE 668398 | Beckman Coulter Inc. | May 26, 2025 | |||
| IVDD Annex IV (excluding sections 4, 6) | CE665104 | IBL International GmbH | May 26, 2025 | |||
| IVDD Annex III Section 6 | 1434-IVDD-268/2022 | TODA PHARMA | May 27, 2025 | |||
| MDD Annex II (excluding section 4) | CE-MDD-0082/09/2020/01 | Laboratories Hyamed SA | Dec 31, 2027 | |||
| MDD Annex II Section 4 | CE-MDD-0082/09/2020/01/DD.01 | Laboratories Hyamed SA | Dec 31, 2027 | |||
| MDD Annex II (excluding section 4) | CE 661378 | United Orthopedic Corporation | Dec 31, 2027 | |||
| MDD Annex II Section 4 | CE 671283 | United Orthopedic Corporation | Dec 31, 2027 | |||
| MDD Annex II Section 4 | CE 661383 | United Orthopedic Corporation | Dec 31, 2027 | |||
| MDD Annex II Section 4 | CE 747894 | United Orthopedic Corporation | Dec 31, 2027 | |||
| MDD Annex II Section 4 | CE 671273 | United Orthopedic Corporation | Dec 31, 2027 | |||
| MDD Annex II Section 4 | CE 671275 | United Orthopedic Corporation | Dec 31, 2027 | |||
| MDD Annex II Section 4 | CE 693526 | United Orthopedic Corporation | Dec 31, 2027 | |||
| MDD Annex II Section 4 | CE 671280 | United Orthopedic Corporation | Dec 31, 2027 | |||
| MDD Annex II Section 4 | CE 671281 | United Orthopedic Corporation | Dec 31, 2027 | |||
| MDD Annex II Section 4 | CE 661380 | United Orthopedic Corporation | Dec 31, 2027 | |||
| MDD Annex II Section 4 | CE 671276 | United Orthopedic Corporation | Dec 31, 2027 | |||
| MDD Annex II Section 4 | CE 671279 | United Orthopedic Corporation | Dec 31, 2027 | |||
| MDD Annex II Section 4 | CE 671277 | United Orthopedic Corporation | Dec 31, 2027 | |||
| MDD Annex II Section 4 | CE 671278 | United Orthopedic Corporation | Dec 31, 2027 | |||
| MDD Annex II Section 4 | CE 587693 | Bioventus LLC | Dec 31, 2027 | |||
| MDD Annex II (excluding section 4) | CE 679150 | Inmet Garnick SA | Dec 31, 2027 | |||
| AIMDD Annex II Section 4 | 634655 | Axonics Inc. | Dec 31, 2027 | |||
| AIMDD Annex II (excluding section 4) | 639686 | Axonics Inc. | Dec 31, 2027 | |||
| AIMDD Annex II Section 4 | 634655 | Axonics Inc. | Dec 31, 2027 | |||
| AIMDD Annex II (excluding section 4) | 639686 | Axonics Inc. | Dec 31, 2027 | |||
| MDD Annex II (excluding section 4) | CE 673072 | OrbusNeich Medical (Shenzhen) Co.,Ltd | Dec 31, 2027 | |||
| MDD Annex II (excluding section 4) | CE 645104 | BioPhotas, Inc. | Dec 31, 2028 | |||
| MDD Annex II (excluding section 4) | 6456GB410210323A | Beijing Kingst Commercial ＆ Trade Co.,Ltd. | Dec 31, 2028 | |||
| MDD Annex II (excluding section 4) | CE 651409 | AtCor Medical Pty Ltd | Dec 31, 2028 | |||
| MDD Annex II (excluding section 4) | 01680 | Braemar Manufacturing, LLC | Dec 31, 2028 | |||
| MDD Annex II (excluding section 4) | CE 587463 | Bioventus LLC | Dec 31, 2028 | |||
| MDD Annex II (excluding section 4) | CE713430 | Shanghai Pulse Medical Technology, Inc. | Dec 31, 2028 | |||
| MDD Annex II (excluding section 4) | CE 713430 | Shanghai Pulse Medical Technology, Inc. | Dec 31, 2028 | |||
| MDD Annex V | CE 687289 | The Alger Company, Inc | Dec 31, 2028 | |||
| MDD Annex II (excluding section 4) | CE539277 | Circle Cardiovascular Imaging Inc | Dec 31, 2028 | |||
| MDD Annex II (excluding section 4) | 675541 | DENTAL MORELLI LTD. | Dec 31, 2028 | |||
| MDD Annex II (excluding section 4) | CE 619984 | OrbusNeich Medical (Shenzhen) Co.,Ltd | Dec 31, 2028 | |||
| MDD Annex II (excluding section 4) | CE 668821 | Surgical Innovations Ltd. | Dec 31, 2028 | |||
| MDD Annex II (excluding section 4) | CE 668821 | Surgical Innovations Ltd. | Dec 31, 2028 | |||
| MDD Annex II (excluding section 4) | CE668821 | Surgical Innovations Ltd. | Dec 31, 2028 |