Notified Body
NB 0344
🇳🇱 Netherlands
DEKRA Certification B.V.
Meander 1051 / P.O. Box 5185, 6825 MJ ARNHEM / 6802 ED ARNHEM, Netherlands
View on EUDAMED
Updated Apr 14, 2023
Certificates
216
Valid
0
Expiring < 6mo
0
Expired
193
Basic UDI-DIs
7327
Devices
7405
Manufacturers
73
Cert. Types
9
Basic Information
- Address
- Meander 1051 / P.O. Box 5185, 6825 MJ ARNHEM / 6802 ED ARNHEM, Netherlands
- [email protected]
- Phone
- +31:(0)88 968 3000
- Website
- www.dekra-product-safety.com
Regulatory Overview
Regulation
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Eu Mdd
7066
Eu Ivdd
246
Eu Aimdd
13
Eu Mdr
2
Classification
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Eu Md Class 3
5291
Eu Md Class 2a
1622
Eu Ivd General
134
Eu Md Class 2b
98
Eu Ivd Annex 2 List B
86
Eu Md Class 1
57
Eu Ivd Annex 2 List A
25
Eu Aimdd Class
13
Eu Ivd Self Testing
1
Device Types
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Certificate Health
Total
216
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
193
Certificates by Expiry Year
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| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| MDD Annex II (excluding section 4) | 3821850CE01 | Magstim Inc. | May 26, 2020 | |||
| MDD Annex II (excluding section 4) | 2217576CE03 | VITROMED GmbH | Sep 30, 2021 | |||
| MDD Annex II Section 4 | 2239487DE02 | VITROMED GmbH | Sep 30, 2021 | |||
| MDD Annex II (excluding section 4) | 318473CE02 | Aroa Biosurgery Ltd. | Apr 11, 2022 | |||
| MDD Annex II (excluding section 4) | 3814738CE01 | Aroa Biosurgery Ltd. | Apr 11, 2022 | |||
| MDD Annex II (excluding section 4) | 3814738CE01 | Aroa Biosurgery Ltd. | Apr 11, 2022 | |||
| MDD Annex II (excluding section 4) | 2110166CE01 | Aqtis Medical B.V. | Aug 01, 2022 | |||
| MDD Annex II Section 4 | '2110166DE01 | Aqtis Medical B.V. | Aug 01, 2022 | |||
| MDD Annex II Section 4 | 2110166DE01 | Aqtis Medical B.V. | Aug 01, 2022 | |||
| MDD Annex II (excluding section 4) | 87756CE02 | SHL Telemedicine International Ltd. | Aug 01, 2022 | |||
| MDD Annex II (excluding section 4) | 2107788DE01 | ASAHI INTECC CO., LTD. | Aug 12, 2022 | |||
| MDD Annex II Section 4 | 2107788CE01 | ASAHI INTECC CO., LTD. | Aug 12, 2022 | |||
| MDD Annex II (excluding section 4) | 93928CE02 | Nutricia Medical Devices BV | Sep 01, 2022 | |||
| MDD Annex II (excluding section 4) | 2107788DE14 | ASAHI INTECC CO., LTD. | Oct 01, 2022 | |||
| MDD Annex II Section 4 | 2107788CE16 | ASAHI INTECC CO., LTD. | Oct 01, 2022 | |||
| MDD Annex II Section 4 | 2107231DE02 | Lifetech Scientific (Shenzhen) Co., Ltd. | Oct 01, 2022 | |||
| MDD Annex II Section 4 | 2107788CE21 | ASAHI INTECC CO., LTD. | Oct 06, 2022 | |||
| MDD Annex II (excluding section 4) | 2017847CE16 | Contract Medical International GmbH | Nov 01, 2022 | |||
| MDD Annex II Section 4 | 2017847DE06 | Contract Medical International GmbH | Nov 01, 2022 | |||
| MDD Annex II (excluding section 4) | 2194636CE03 | Assut Medical Sàrl | Dec 12, 2022 | |||
| MDD Annex II Section 4 | 2194636DE03 | Assut Medical Sàrl | Dec 12, 2022 | |||
| MDD Annex II Section 4 | 2107788CE27 | ASAHI INTECC CO., LTD. | Dec 31, 2022 | |||
| MDD Annex V | 2116136CE01 | BioProtect | Jan 01, 2023 | |||
| MDD Annex II (excluding section 4) | 2017847CE20 | Contract Medical International GmbH | Jan 01, 2023 | |||
| MDD Annex II (excluding section 4) | 2084956CE01 | Plasma Surgical, Inc. | Jan 01, 2023 | |||
| MDD Annex II (excluding section 4) | 2079177CE01 | Philips Medical Systems Nederland B.V. | Feb 01, 2023 | |||
| MDD Annex II Section 4 | 2107788CE11 | ASAHI INTECC CO., LTD. | Feb 01, 2023 | |||
| MDD Annex II Section 4 | 2107231DE06 | Lifetech Scientific (Shenzhen) Co., Ltd. | Mar 01, 2023 | |||
| MDD Annex II (excluding section 4) | 2107788DE18 | ASAHI INTECC CO., LTD. | Apr 01, 2023 | |||
| MDD Annex II Section 4 | 2107788CE22 | ASAHI INTECC CO., LTD. | Apr 01, 2023 | |||
| MDD Annex II Section 4 | 2107788CE17 | ASAHI INTECC CO., LTD. | Apr 19, 2023 | |||
| MDD Annex II (excluding section 4) | 2107788DE06 | ASAHI INTECC CO., LTD. | Apr 22, 2023 | |||
| MDD Annex II Section 4 | 2107788CE06 | ASAHI INTECC CO., LTD. | Apr 22, 2023 | |||
| MDD Annex V | 2085393CE01 | DiagnOptics Technologies B.V. | May 01, 2023 | |||
| MDD Annex II (excluding section 4) | 2107788DE22 | ASAHI INTECC CO., LTD. | May 09, 2023 | |||
| MDD Annex II Section 4 | 2107788CE28 | ASAHI INTECC CO., LTD. | May 09, 2023 | |||
| MDD Annex II (excluding section 4) | 3815223CE01 | Measurement Specialties Inc. | Jun 06, 2023 | |||
| MDD Annex II (excluding section 4) | 3815223CE02 | Measurement Specialties Inc. | Jun 06, 2023 | |||
| MDD Annex II (excluding section 4) | 3815223CE03 | Measurement Specialties Inc. | Jun 06, 2023 | |||
| MDD Annex II Section 4 | 2107788CE29 | ASAHI INTECC CO., LTD. | Jun 25, 2023 | |||
| MDD Annex II (excluding section 4) | 2194267CE01 | U-Needle | Jul 01, 2023 | |||
| MDD Annex V | 2002709CE01 | Forum Engineering Technologies (96) Ltd. | Jul 01, 2023 | |||
| MDD Annex V | 2002709EC01 | Forum Engineering Technologies (96) Ltd. | Jul 01, 2023 | |||
| MDD Annex II (excluding section 4) | 2225435CE01 | Sino Medical Sciences Technology Inc. | Jul 01, 2023 | |||
| MDD Annex II Section 4 | 2225435DE01 | Sino Medical Sciences Technology Inc. | Jul 01, 2023 | |||
| MDD Annex II (excluding section 4) | 2225435CE01 | Sino Medical Sciences Technology Inc. | Jul 01, 2023 | |||
| MDD Annex II Section 4 | 2225435DE01 | Sino Medical Sciences Technology Inc. | Jul 01, 2023 | |||
| MDD Annex II (excluding section 4) | 2225435CE01 | Sino Medical Sciences Technology Inc. | Jul 01, 2023 | |||
| MDD Annex II (excluding section 4) | 2125546CE01 | IOPtima Ltd. | Jul 01, 2023 | |||
| MDD Annex V | 2126992CE02 | Cassini Technologies B.V | Jul 01, 2023 | |||
| MDD Annex II (excluding section 4) | 2107788DE19 | ASAHI INTECC CO., LTD. | Jul 05, 2023 | |||
| MDD Annex II Section 4 | 2107788CE23 | ASAHI INTECC CO., LTD. | Jul 05, 2023 | |||
| MDD Annex II (excluding section 4) | 2123758CE01 | Augma Biomaterials | Aug 01, 2023 | |||
| MDD Annex II Section 4 | 2123758DE01 | Augma Biomaterials | Aug 01, 2023 | |||
| MDD Annex II (excluding section 4) | 2013772CE01 | Dyna Dental Engineering B.V. | Aug 01, 2023 | |||
| MDD Annex II Section 4 | 2107788CE03 | ASAHI INTECC CO., LTD. | Sep 01, 2023 | |||
| MDD Annex II (excluding section 4) | 2107788DE03 | ASAHI INTECC CO., LTD. | Sep 01, 2023 | |||
| MDD Annex II (excluding section 4) | 2217576CE04 | VITROMED GmbH | Sep 30, 2023 | |||
| MDD Annex II Section 4 | 2217576DE01 | VITROMED GmbH | Sep 30, 2023 | |||
| MDD Annex II (excluding section 4) | 2217576CE02 | VITROMED GmbH | Sep 30, 2023 | |||
| MDD Annex V | 96395CE02 | Royal Utermöhlen | Oct 01, 2023 | |||
| MDD Annex II (excluding section 4) | 3816651CE02 | Molteno Ophthalmic Limited | Oct 20, 2023 | |||
| MDD Annex II (excluding section 4) | 2109122CE01 | Technomed Europe | Oct 31, 2023 | |||
| MDD Annex V | 2109122CE02 | Technomed Europe | Oct 31, 2023 | |||
| MDD Annex II (excluding section 4) | 2181543CE01 | ScreenPoint Medical | Dec 01, 2023 | |||
| MDD Annex V | 2174842CE01 | TauroPharm GmbH | Jan 29, 2024 | |||
| MDD Annex II (excluding section 4) | 2174842CE02 | TauroPharm GmbH | Jan 29, 2024 | |||
| MDD Annex II Section 4 | 2094913DE01 | Bioretec Ltd. | Jan 31, 2024 | |||
| MDD Annex III | 2094913DE06 | Bioretec Ltd. | Jan 31, 2024 | |||
| MDD Annex II Section 4 | 2094913DE05 | Bioretec Ltd. | Feb 01, 2024 | |||
| MDD Annex II (excluding section 4) | 2094913CE01 | Bioretec Ltd. | Feb 01, 2024 | |||
| MDD Annex II (excluding section 4) | 3901646CE01 | CathWorks Ltd. | Mar 01, 2024 | |||
| MDD Annex II (excluding section 4) | 2131708CE01 | Bonalive Ltd | Mar 01, 2024 | |||
| MDD Annex II Section 4 | 2131708DE01 | Bonalive Ltd | Mar 01, 2024 | |||
| MDD Annex II Section 4 | 2131708DE01 | Bonalive Ltd | Mar 01, 2024 | |||
| MDD Annex II (excluding section 4) | 2131708CE01 | Bonalive Ltd | Mar 01, 2024 | |||
| MDD Annex II (excluding section 4) | 2107788DE10 | ASAHI INTECC CO., LTD. | Mar 15, 2024 | |||
| MDD Annex II Section 4 | 2107788CE12 | ASAHI INTECC CO., LTD. | Mar 15, 2024 | |||
| MDD Annex II (excluding section 4) | 2116857CE08 | Biosensors Europe SA | Apr 01, 2024 | |||
| MDD Annex II Section 4 | 2116857DE08 | Biosensors Europe SA | Apr 01, 2024 | |||
| MDD Annex II Section 4 | 2116857DE08 | Biosensors Europe SA | Apr 01, 2024 | |||
| MDD Annex II (excluding section 4) | 2217576CE01 | VITROMED GmbH | Apr 24, 2024 | |||
| MDD Annex II (excluding section 4) | V-ICSIPET INJECTION 2217576CE01 | VITROMED GmbH | Apr 24, 2024 | |||
| MDD Annex II (excluding section 4) | 2107788DE20 | ASAHI INTECC CO., LTD. | May 01, 2024 | |||
| MDD Annex II Section 4 | 2107788CE24 | ASAHI INTECC CO., LTD. | May 01, 2024 | |||
| MDD Annex V | 3900792CE01 | iMDsoft Gmbh | May 01, 2024 | |||
| MDD Annex II (excluding section 4) | 2007326CE01 | iMDsoft Ltd | May 01, 2024 | |||
| MDD Annex II (excluding section 4) | 3902551CE01 | Sofwave Medical Ltd. | May 01, 2024 | |||
| MDD Annex II (excluding section 4) | 2228386CE01 | Microsure B.V. | May 01, 2024 | |||
| MDD Annex II (excluding section 4) | 2107788DE15 | ASAHI INTECC CO., LTD. | May 16, 2024 | |||
| MDD Annex II Section 4 | 2107788CE18 | ASAHI INTECC CO., LTD. | May 16, 2024 | |||
| MDD Annex II (excluding section 4) | 3810167CE01 | Attune Medical | May 24, 2024 | |||
| MDD Annex II (excluding section 4) | 2017847CE05 | Contract Medical International GmbH | May 25, 2024 | |||
| MDD Annex II (excluding section 4) | 2141980CE02 | Shanghai MicroPort Medical (Group) Co., Ltd. | May 25, 2024 | |||
| MDD Annex II Section 4 | 2238049DE01 | ANACONDA BIOMED, S.L. | May 25, 2024 | |||
| MDD Annex II (excluding section 4) | 2238049CE01 | ANACONDA BIOMED, S.L. | May 25, 2024 | |||
| AIMDD Annex II (excluding section 4) | 2223241CE01 | Aleva Neurotherapeutics SA | May 25, 2024 | |||
| MDD Annex II (excluding section 4) | 6059576CE01 | Ezisurg Medical Co., Ltd | May 25, 2024 | |||
| MDD Annex II (excluding section 4) | 6085114CE01 | Henan Simedice Biotechnologies Co.,Ltd. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 2107788DE11 | ASAHI INTECC CO., LTD. | May 26, 2024 | |||
| MDD Annex II Section 4 | 2107788CE13 | ASAHI INTECC CO., LTD. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 2107788DE23 | ASAHI INTECC CO., LTD. | May 26, 2024 | |||
| MDD Annex II Section 4 | 2107788CE30 | ASAHI INTECC CO., LTD. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 2107788DE17 | ASAHI INTECC CO., LTD. | May 26, 2024 | |||
| MDD Annex II Section 4 | 2107788CE20 | ASAHI INTECC CO., LTD. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 2107788DE09 | ASAHI INTECC CO., LTD. | May 26, 2024 | |||
| MDD Annex II Section 4 | 2107788CE10 | ASAHI INTECC CO., LTD. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 6092261CE01 | Besmed Health Business Corp. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 6192261CE01 | Besmed Health Business Corp. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 3804606CE01 | CytoSorbents Inc. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 2181711CE01 | Bioptimal International PTE. LTD. | May 26, 2024 | |||
| MDD Annex II Section 4 | 2181711DE02 | Bioptimal International PTE. LTD. | May 26, 2024 | |||
| MDD Annex II Section 4 | 2181711DE03 | Bioptimal International PTE. LTD. | May 26, 2024 | |||
| MDD Annex II Section 4 | 2181711DE01 | Bioptimal International PTE. LTD. | May 26, 2024 | |||
| MDD Annex V | 65263CE02 | Humeca B.V. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 3823657CE01 | Align Technology Inc. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 3803643CE01 | ClearPoint Neuro, Inc. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 2178371CE01 | Philips Healthcare Informatics, Inc. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 2076971CE01 | TEIJIN MEDICAL TECHNOLOGIES CO., LTD. | May 26, 2024 | |||
| MDD Annex II Section 4 | 2107231CE01 and 2107231DE08 | Lifetech Scientific (Shenzhen) Co., Ltd. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 3823489CE01 | Next Science LLC | May 26, 2024 | |||
| MDD Annex II Section 4 | 2107788CE09 | ASAHI INTECC CO., LTD. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 2107788DE24 | ASAHI INTECC CO., LTD. | May 26, 2024 | |||
| MDD Annex II Section 4 | 2107788CE31 | ASAHI INTECC CO., LTD. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 2107788DE21 | ASAHI INTECC CO., LTD. | May 26, 2024 | |||
| MDD Annex II Section 4 | 2107788CE25 | ASAHI INTECC CO., LTD. | May 26, 2024 | |||
| MDD Annex II Section 4 | 2107788CE26 | ASAHI INTECC CO., LTD. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 2107788DE13 | ASAHI INTECC CO., LTD. | May 26, 2024 | |||
| MDD Annex II Section 4 | 2107788CE15 | ASAHI INTECC CO., LTD. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 3805232CE01 | eNeura, Inc. | May 26, 2024 | |||
| MDD Annex II Section 4 | 2116232DE01 | MDT Int'l SA | May 26, 2024 | |||
| MDD Annex II Section 4 | 2116232DE02 | MDT Int'l SA | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | B293HFT110E0 | MIVI Neuroscience | May 26, 2024 | |||
| MDD Annex II Section 4 | 3814622DE02 | MIVI Neuroscience | May 26, 2024 | |||
| MDD Annex II Section 4 | B293Q669145E0 | MIVI Neuroscience | May 26, 2024 | |||
| MDD Annex II Section 4 | B293Q557145E0 | MIVI Neuroscience | May 26, 2024 | |||
| MDD Annex II Section 4 | B293Q443150E0 | MIVI Neuroscience | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 3814622DE01 | MIVI Neuroscience | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 6069514CE01 | Aike (Shanghai) Medical Instrument Co., Ltd | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 6051918CE01 | Hunan Vathin Medical Instrument Co., Ltd. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 2110499CE01 | IBSA Pharma SAS | May 26, 2024 | |||
| MDD Annex II Section 4 | 2107466DE02 | Aziyo Biologics, Inc. | May 26, 2024 | |||
| MDD Annex II Section 4 | 2107466DE03 | Aziyo Biologics, Inc. | May 26, 2024 | |||
| MDD Annex II Section 4 | 2107466DE01 | Aziyo Biologics, Inc. | May 26, 2024 | |||
| MDD Annex II Section 4 | 2141980DE02 | Shanghai MicroPort Medical (Group) Co., Ltd. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 2141980CE01 | Shanghai MicroPort Medical (Group) Co., Ltd. | May 26, 2024 | |||
| MDD Annex II Section 4 | 2141980DE03 | Shanghai MicroPort Medical (Group) Co., Ltd. | May 26, 2024 | |||
| MDD Annex II Section 4 | 2141980DE04 | Shanghai MicroPort Medical (Group) Co., Ltd. | May 26, 2024 | |||
| MDD Annex V | 653263CE02 | Humeca B.V. | May 26, 2024 | |||
| MDD Annex V | 65263CE01 | Humeca B.V. | May 26, 2024 | |||
| MDD Annex V | 65263CE0 | Humeca B.V. | May 26, 2024 | |||
| MDD Annex V | 2113218CE01 | Boegem Gezondheidszorg B.V. | May 26, 2024 | |||
| MDD Annex V | 2173979CE01 | Novuqare Pelvic Health B.V. | May 26, 2024 | |||
| MDD Annex V | 96395CE05 | Royal Utermöhlen | May 26, 2024 | |||
| MDD Annex V | Humeca D42 Dermatome blade, 10 pcs | Humeca B.V. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 2107231CE01 | Lifetech Scientific (Shenzhen) Co., Ltd. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | Fustar™ Steerable Introducer | Lifetech Scientific (Shenzhen) Co., Ltd. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | SteerEase™ Introducer | Lifetech Scientific (Shenzhen) Co., Ltd. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | SteerEase™ Introducer | Lifetech Scientific (Shenzhen) Co., Ltd. | May 26, 2024 | |||
| MDD Annex II Section 4 | 2107231DE07 | Lifetech Scientific (Shenzhen) Co., Ltd. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 2115297CN | Rolf Kullgren AB | May 26, 2024 | |||
| MDD Annex II Section 4 | 2115297CE01 | Rolf Kullgren AB | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 160841CE01 | NP Medical, Inc. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 993928CE01 | Nutricia Medical Devices BV | May 26, 2024 | |||
| MDD Annex II Section 4 | 3821521DE | Fibralign Corporation | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 3821521CE | Fibralign Corporation | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 2110499CE | IBSA Pharma SAS | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 256 ch GTEN 200 Research Conversion Package from Geodesic EEG System (GES) 400 | Magstim Inc. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 3821850CE01 | Magstim Inc. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 3821850CE01 | Magstim Inc. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 3821850CE01 | Magstim Inc. | May 26, 2024 | |||
| MDD Annex II Section 4 | 2107466CE02 | Aziyo Biologics, Inc. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 2017847CE25 | Contract Medical International GmbH | May 26, 2024 | |||
| MDD Annex II Section 4 | 2107231DE01 | Lifetech Scientific (Shenzhen) Co., Ltd. | May 26, 2024 | |||
| MDD Annex V | 2238613CE01 | Phlecs B.V. | May 27, 2024 | |||
| MDD Annex II Section 4 | 93928CE01 | Nutricia Medical Devices BV | May 29, 2024 | |||
| IVDD Annex IV (excluding sections 4, 6) | 3822623 | LGC Clinical Diagnostics, Inc. | Oct 02, 2024 | |||
| IVDD Annex IV (excluding sections 4, 6) | 2114921 | IQ Products BV | Feb 01, 2025 | |||
| IVDD Annex IV (excluding sections 4, 6) | 2114129CE01 | IQ Products BV | May 26, 2025 | |||
| IVDD Annex IV (excluding sections 4, 6) | 2231396CE01 | LifeScan Europe GmbH | May 26, 2025 | |||
| IVDD Annex IV (excluding sections 4, 6) | 2116030CE02 | General Biologicals Corporation | May 26, 2025 | |||
| IVDD Annex IV Section 4 | 2116030DE08 | General Biologicals Corporation | May 26, 2025 | |||
| IVDD Annex IV (excluding sections 4, 6) | 2116030CE01 | General Biologicals Corporation | May 26, 2025 | |||
| IVDD Annex IV Section 4 | 2116030DE02 | General Biologicals Corporation | May 26, 2025 | |||
| IVDD Annex IV Section 4 | 2116030DE09 | General Biologicals Corporation | May 26, 2025 | |||
| IVDD Annex IV Section 4 | 2116030DE06 | General Biologicals Corporation | May 26, 2025 | |||
| IVDD Annex IV Section 4 | 2116030DE04 | General Biologicals Corporation | May 26, 2025 | |||
| IVDD Annex IV Section 4 | 2116030DE10 | General Biologicals Corporation | May 26, 2025 | |||
| IVDD Annex IV Section 4 | 2116030DE03 | General Biologicals Corporation | May 26, 2025 | |||
| IVDD Annex IV Section 4 | 2116030DE07 | General Biologicals Corporation | May 26, 2025 | |||
| IVDD Annex IV (excluding sections 4, 6) | 2116030CE04 | General Biologicals Corporation | May 26, 2025 | |||
| IVDD Annex IV Section 4 | 2116030DE11 | General Biologicals Corporation | May 26, 2025 | |||
| MDR QMS | 2245855CE01 | Aidence B.V. | MDR | Oct 2020 | Oct 01, 2025 | Issued |
| MDD Annex II Section 4 | 2117262DE02 | Spierings Orthopaedics B.V. | Dec 31, 2027 | |||
| MDD Annex II (excluding section 4) | 2117262CE01 | Spierings Orthopaedics B.V. | Dec 31, 2027 | |||
| MDD Annex II (excluding section 4) | 2174771CE01 | Merlin MD Pte. Ltd. | Dec 31, 2027 | |||
| MDD Annex II Section 4 | 2174771DE01 | Merlin MD Pte. Ltd. | Dec 31, 2027 | |||
| MDD Annex II (excluding section 4) | 2174771CE1 | Merlin MD Pte. Ltd. | Dec 31, 2027 | |||
| MDD Annex II Section 4 | 2174771DE02 | Merlin MD Pte. Ltd. | Dec 31, 2027 | |||
| MDD Annex II Section 4 | 2166785CE03&2166785DE11 | LifeTech Scientific (Europe) B.V. | Dec 31, 2027 | |||
| MDD Annex II Section 4 | 2166785CE03&2166785DE08 | LifeTech Scientific (Europe) B.V. | Dec 31, 2027 | |||
| MDD Annex II Section 4 | 2166785CE03&2166785DE09 | LifeTech Scientific (Europe) B.V. | Dec 31, 2027 | |||
| MDD Annex II Section 4 | 2166785CE03&2166785DE08 | LifeTech Scientific (Europe) B.V. | Dec 31, 2027 | |||
| MDD Annex II Section 4 | Ankura™ TAA Stent Graft System | LifeTech Scientific (Europe) B.V. | Dec 31, 2027 | |||
| MDD Annex II Section 4 | 2166785CE03&2166785DE11 | LifeTech Scientific (Europe) B.V. | Dec 31, 2027 | |||
| MDD Annex II Section 4 | 2166785CE03&2166785DE12 | LifeTech Scientific (Europe) B.V. | Dec 31, 2027 | |||
| MDD Annex II Section 4 | 2166785CE03&2166785DE12 | LifeTech Scientific (Europe) B.V. | Dec 31, 2027 | |||
| MDD Annex II (excluding section 4) | 2116857CE05 | Biosensors Europe SA | Dec 31, 2027 | |||
| MDD Annex II Section 4 | 2116857DE04 | Biosensors Europe SA | Dec 31, 2027 | |||
| MDD Annex II (excluding section 4) | 2116857CE05 | Biosensors Europe SA | Dec 31, 2027 | |||
| MDD Annex II Section 4 | 2116857DE04 | Biosensors Europe SA | Dec 31, 2027 | |||
| MDD Annex II Section 4 | 2116857DE09 | Biosensors Europe SA | Dec 31, 2027 | |||
| MDD Annex V | 2121250CE01 | Dörr Kampen B.V. | Dec 31, 2028 | |||
| MDD Annex II (excluding section 4) | 2166785CE03 | LifeTech Scientific (Europe) B.V. | Dec 31, 2028 | |||
| MDR Technical Documentation | 3902997TD01 | BioProtect | — | |||
| MDR Technical Documentation | 3829984TD01 | Cardiac Dimensions, Inc. | — |