Notified Body
NB 0297
🇩🇪 Germany
DQS Medizinprodukte GmbH
August-Schanz-Straße 21, 60433 FRANKFURT AM MAIN, Germany
View on EUDAMED
Updated Sep 8, 2023
Certificates
144
Valid
21
Expiring < 6mo
1
Expired
106
Basic UDI-DIs
6387
Devices
6426
Manufacturers
72
Cert. Types
7
Basic Information
- Address
- August-Schanz-Straße 21, 60433 FRANKFURT AM MAIN, Germany
- [email protected]
- Phone
- +49 69 95427 300
Regulatory Overview
Regulation
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Eu Mdd
6374
Eu Mdr
13
Classification
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Eu Md Class 3
5243
Eu Md Class 2a
598
Eu Md Class 2b
366
Eu Md Class 1
180
Device Types
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Certificate Health
Total
144
Valid
21
Expiring < 6mo
1
Expired / Withdrawn
108
Certificates by Expiry Year
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| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| MDD Annex II (excluding section 4) | 170683274 | OrthAlign, Inc | Sep 08, 2022 | |||
| MDD Annex II Section 4 | 455382 MR2 | Telemis GmbH | Jan 16, 2023 | |||
| MDD Annex V | 535578 MR5 | Sanavita Pharmaceuticals GmbH | Mar 14, 2023 | |||
| MDD Annex II (excluding section 4) | 170769851 | Lombard Medical Limited | Mar 15, 2023 | |||
| MDD Annex II Section 4 | 170769617 | Perflow Medical Ltd. | May 27, 2023 | |||
| MDD Annex II Section 4 | 520368 | 41medical AG | Jul 20, 2023 | |||
| MDD Annex II (excluding section 4) | 004911 MR2 | W&H Dentalwerk Bürmoos GmbH | Aug 02, 2023 | |||
| MDD Annex II Section 4 | 004911 NR2 | W&H Dentalwerk Bürmoos GmbH | Aug 02, 2023 | |||
| MDD Annex II (excluding section 4) | 335325 MR2 | Haag-Streit AG | Jan 17, 2024 | |||
| MDD Annex II (excluding section 4) | 474064 | Scientia Vascular, Inc. | Feb 02, 2024 | |||
| MDD Annex II (excluding section 4) | 474064 | Scientia Vascular, Inc. | Feb 02, 2024 | |||
| MDD Annex V | 170722416 | Pulse for Integrated Solutions GmbH | Feb 10, 2024 | |||
| MDD Annex IV | 170722415 | Pulse for Integrated Solutions GmbH | Feb 10, 2024 | |||
| MDD Annex II (excluding section 4) | 170739408 | HOSPITAL TECHNICAL SOLUTIONS SRL | Feb 17, 2024 | |||
| MDD Annex II (excluding section 4) | 527935 MR2 | HOSPITAL TECHNICAL SOLUTIONS SRL | Feb 17, 2024 | |||
| MDD Annex II (excluding section 4) | 230521 MR2 | FUJIFILM medwork GmbH | Feb 27, 2024 | |||
| MDD Annex II (excluding section 4) | 013536MR2 | EPflex Feinwerktechnik GmbH | Mar 21, 2024 | |||
| MDD Annex II (excluding section 4) | 013536 | EPflex Feinwerktechnik GmbH | Mar 21, 2024 | |||
| MDD Annex II (excluding section 4) | 013536 MR2 | EPflex Feinwerktechnik GmbH | Mar 21, 2024 | |||
| MDD Annex II (excluding section 4) | 059786 MR2 170726773 | Pro-Dex, Inc. | Mar 29, 2024 | |||
| MDD Annex II (excluding section 4) | 300042 MR2 | Anton Hübner GmbH & Co. KG | Mar 31, 2024 | |||
| MDD Annex II (excluding section 4) | 30042 MR2 | Anton Hübner GmbH & Co. KG | Mar 31, 2024 | |||
| MDD Annex II Section 4 | 170774418 | BHM-Tech Produktionsgesellschaft m.b.H. | Apr 04, 2024 | |||
| MDD Annex II (excluding section 4) | 170768616 | SPIGGLE & THEIS Medizintechnik GmbH | Apr 08, 2024 | |||
| MDD Annex II (excluding section 4) | 170769583 | Albutec GmbH | May 25, 2024 | |||
| MDD Annex II (excluding section 4) | 170748888 | Profil Institut für Stoffwechselforschung GmbH | May 25, 2024 | |||
| MDD Annex II (excluding section 4) | 17074888 | Profil Institut für Stoffwechselforschung GmbH | May 25, 2024 | |||
| MDD Annex II (excluding section 4) | 170771754 | BSC Medical Devices GmbH | May 25, 2024 | |||
| MDD Annex II (excluding section 4) | 170770754 | BSC Medical Devices GmbH | May 25, 2024 | |||
| MDD Annex II (excluding section 4) | 170775522 | Pharmpur GmbH | May 25, 2024 | |||
| MDD Annex II (excluding section 4) | 530381 MR2 | Sanavita Pharmaceuticals GmbH | May 25, 2024 | |||
| MDD Annex II Section 4 | 539949 MRA | Medical Magnesium GmbH | May 25, 2024 | |||
| MDD Annex II Section 4 | 548133 MRA | Medical Magnesium GmbH | May 25, 2024 | |||
| MDD Annex II (excluding section 4) | 548966 MR2 | Taiyo Nippon Sanso Corporation | May 25, 2024 | |||
| MDD Annex II (excluding section 4) | 170769962 | ITH icoserve technology for healthcare GmbH | May 25, 2024 | |||
| MDD Annex II (excluding section 4) | 843847 MR2 | Osstell AB | May 25, 2024 | |||
| MDD Annex V | 170756407 | ADTMed | May 26, 2024 | |||
| MDD Annex V | 170773732 | ADTMed | May 26, 2024 | |||
| MDD Annex V | 543045 MR5 | SureflO2 Trading Pty Ltd | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 170741417 | audifon GmbH & Co. KG | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 540287 MR2 | HumanTech Spine GmbH | May 26, 2024 | |||
| MDD Annex II Section 4 | 544291 MRA | MicroPort NeuroTech (Shanghai) Co.,Ltd. | May 26, 2024 | |||
| MDD Annex II Section 4 | 3D0820FR | MicroPort NeuroTech (Shanghai) Co.,Ltd. | May 26, 2024 | |||
| MDD Annex II Section 4 | 3D0520FR | MicroPort NeuroTech (Shanghai) Co.,Ltd. | May 26, 2024 | |||
| MDD Annex II Section 4 | 544291MRA | MicroPort NeuroTech (Shanghai) Co.,Ltd. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 170776241 | BALT USA LLC | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 170739529 | EnvisionTEC GmbH | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 543722 MR2 | Adhe-Els SA. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 543722 MR2 | Adhe-Els SA. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 170759665 | Prymax Healthcare LLP | May 26, 2024 | |||
| MDD Annex V | 546003 MR5 | Livac Pty Ltd | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 529049 MR2 | Medical Templates AG | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 170767846 | DELTEX | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 170767846 | DELTEX | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 527544 MR2 | VEPRO AG | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 532639 MR2 | AGOMED Medizin-Technik GmbH | May 26, 2024 | |||
| MDD Annex V | 381008 | KAZ Europe Sàrl | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 527201 MR2 | Pixmeo SARL | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 523992 MR2 | LENICURA GmbH | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 170775883 | Navbit Pty Ltd | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 541616 MR2 | Navbit Pty Ltd | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 170770416 | KLS Martin GmbH + Co. KG | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 170776129 | Meril Life Sciences Pvt. Ltd. | May 26, 2024 | |||
| MDD Annex II Section 4 | 170776132 | Meril Life Sciences Pvt. Ltd. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 170776129 | Meril Life Sciences Pvt. Ltd. | May 26, 2024 | |||
| MDD Annex II Section 4 | 170776132 | Meril Life Sciences Pvt. Ltd. | May 26, 2024 | |||
| MDD Annex II Section 4 | 170776133 | Meril Life Sciences Pvt. Ltd. | May 26, 2024 | |||
| MDD Annex II Section 4 | 170776133 | Meril Life Sciences Pvt. Ltd. | May 26, 2024 | |||
| MDD Annex II Section 4 | 544486 MRA | Chitogel Limited | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 544165 | Summus Medical Laser | May 26, 2024 | |||
| MDD Annex II Section 4 | 170766821 | Medical Magnesium GmbH | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 541873 MR2 | RRR Manufacturing Pty Ltd | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 543722MR2 | Adhe-Els SA. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 170776053 | PD NEUROTECHNOLOGY LTD. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 533257 | avateramedical GmbH | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 533257 MR2 | avateramedical GmbH | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 523027 MR2 | Naturelize GmbH | May 26, 2024 | |||
| MDD Annex II Section 4 | 013536MRA | EPflex Feinwerktechnik GmbH | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 085646 MR2 | Pharmpur GmbH | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 058646 MR2 | Pharmpur GmbH | May 26, 2024 | |||
| MDD Annex II Section 4 | 170771902 | Perflow Medical Ltd. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 544165 | Summus Medical Laser | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 544291 MR2 | MicroPort NeuroTech (Shanghai) Co.,Ltd. | May 26, 2024 | |||
| MDD Annex II Section 4 | 544291 MRA | MicroPort NeuroTech (Shanghai) Co.,Ltd. | May 26, 2024 | |||
| MDD Annex II Section 4 | 544291 MRA | MicroPort NeuroTech (Shanghai) Co.,Ltd. | May 26, 2024 | |||
| MDD Annex II Section 4 | 544291 MRA | MicroPort NeuroTech (Shanghai) Co.,Ltd. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 544291 MRA 544291 MR2 | MicroPort NeuroTech (Shanghai) Co.,Ltd. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 544291 MR2 | MicroPort NeuroTech (Shanghai) Co.,Ltd. | May 26, 2024 | |||
| MDD Annex II Section 4 | 17077132 | Meril Life Sciences Pvt. Ltd. | May 26, 2024 | |||
| MDD Annex II Section 4 | 170776134 | Meril Life Sciences Pvt. Ltd. | May 26, 2024 | |||
| MDD Annex II Section 4 | 170776134 | Meril Life Sciences Pvt. Ltd. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 333413 MR2 | Dr. Kleine Pharma GmbH | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 520368 | 41medical AG | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 004260260050290 | Pharmpur GmbH | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 04260260050276 | Pharmpur GmbH | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 04260260050269 | Pharmpur GmbH | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 04260260050252 | Pharmpur GmbH | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 004260260050757 | Pharmpur GmbH | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 170775751 | Dr. Kleine Pharma GmbH | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 520594 | Shape Memory Medical Inc | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 390353 MR2 | SOMNOmedics AG | May 26, 2024 | |||
| MDD Annex II Section 4 | 542595 MRA | ALN | May 26, 2024 | |||
| MDD Annex II Section 4 | 548447 MRA | ALN | May 26, 2024 | |||
| MDD Annex II Section 4 | 548460 MRA | ALN | May 26, 2024 | |||
| MDD Annex II Section 4 | 170769037 | Scaffdex Oy | May 26, 2024 | |||
| MDD Annex II Section 4 | 544291 MRA | MicroPort NeuroTech (Shanghai) Co.,Ltd. | Jan 17, 2025 | |||
| MDR QMS | 1000186556 | synedra information technologies GmbH | MDR | Jul 2024 | Dec 01, 2026 | Supplemented |
| MDR Technical Documentation | 170780826 | synedra information technologies GmbH | MDR | Jul 2022 | Dec 15, 2026 | Withdrawn |
| MDR QMS | 170778794 | DÜRR DENTAL SE | MDR | Mar 2022 | Mar 10, 2027 | Issued |
| MDR Technical Documentation | 170780332 | Route 92 Medical, Inc. | MDR | May 2022 | May 18, 2027 | Issued |
| MDR QMS | 170776070 | Route 92 Medical, Inc. | MDR | May 2022 | May 18, 2027 | Issued |
| MDR Technical Documentation | 170775962 | Haag-Streit AG | MDR | Jul 2022 | Jul 06, 2027 | Issued |
| MDR QMS | 170775963 | Haag-Streit AG | MDR | Jul 2022 | Jul 06, 2027 | Issued |
| MDR Technical Documentation | 170783362 | BioQ Pharma Incorporated | MDR | Feb 2023 | Aug 24, 2027 | Withdrawn |
| MDR QMS | 1000169817 | BioQ Pharma Incorporated | MDR | Apr 2024 | Aug 24, 2027 | Amended |
| MDR QMS | 170779128 | Balt extrusion SAS | MDR | Sep 2022 | Sep 01, 2027 | Issued |
| MDR Technical Documentation | 170779129 | Balt extrusion SAS | MDR | Sep 2022 | Sep 01, 2027 | Issued |
| MDR QMS | 1000169818 | Perflow Medical Ltd. | MDR | May 2024 | Oct 06, 2027 | Supplemented |
| MDR Technical Documentation | 170781760 | Perflow Medical Ltd. | MDR | Oct 2022 | Oct 06, 2027 | Issued |
| MDR Technical Documentation | 170782485 | Acutus Medical, Inc. | MDR | Feb 2023 | Nov 14, 2027 | Issued |
| MDR QMS | 1000165613 | Acutus Medical, Inc. | MDR | Feb 2024 | Nov 14, 2027 | Issued |
| MDR QMS | 1000164455 | Huma Therapeutics Limited | MDR | Feb 2024 | Mar 01, 2028 | Issued |
| MDR Technical Documentation | 170781274 | Huma Therapeutic Limited | MDR | Mar 2023 | Mar 01, 2028 | Issued |
| MDR QMS | 170781278 | Huma Therapeutic Limited | MDR | Mar 2023 | Mar 01, 2028 | Issued |
| MDR Technical Documentation | 170783435 | Perflow Medical Ltd. | MDR | Mar 2023 | Mar 02, 2028 | Issued |
| MDD Annex II (excluding section 4) | 170771265 | Noruco SL | May 26, 2028 | |||
| MDR Technical Documentation | 1000131095 | Acutus Medical, Inc. | MDR | Aug 2023 | Aug 20, 2028 | Issued |
| MDR QMS | 170781682 | Lombard Medical Limited | MDR | Dec 2023 | Dec 20, 2028 | Issued |
| MDD Annex II (excluding section 4) | 170726773 | Pro-Dex, Inc. | Dec 31, 2028 | |||
| MDD Annex II (excluding section 4) | 1000171969 | Ecolab Deutschland GmbH | Dec 31, 2028 | |||
| MDR Technical Documentation | 1000166386 | Acutus Medical, Inc. | MDR | Feb 2024 | Feb 21, 2029 | Issued |
| MDR QMS | 1000116096 | Simq GmbH | MDR | May 2024 | May 01, 2029 | Issued |
| MDD Annex II Section 4 | 548900 MRA | Medical Magnesium GmbH | May 25, 2042 | |||
| MDR Technical Documentation | 31619290 MDR2017P | Acutus Medical, Inc. | — | |||
| MDR Type Examination | 170781274 | Huma Therapeutics Limited | — | |||
| MDR Technical Documentation | 1000166386 | Acutus Medical, Inc. | — | |||
| MDR Type Examination | 170779401 | 170779445 | synedra information technologies GmbH | — | |||
| MDR Type Examination | 335325 MDR2017B | Haag-Streit AG | — | |||
| MDR Technical Documentation | 513975 MDR2017P | Balt extrusion SAS | — | |||
| MDR Technical Documentation | 542544 MDR2017P | Perflow Medical Ltd. | — | |||
| MDR Technical Documentation | 170781996 | Acutus Medical, Inc. | — | |||
| MDR Technical Documentation | 170781760 | Perflow Medical Ltd. | — | |||
| MDR Technical Documentation | 170780332 | Route 92 Medical, Inc. | — | |||
| MDR Type Examination | 512328 MR2 | BioQ Pharma Incorporated | — |