Notified Body
NB 0044
🇩🇪 Germany
TÜV NORD CERT GmbH
Am TÜV 1, 45307 Essen, Germany
View on EUDAMED
Updated Sep 21, 2022
Certificates
27
Valid
2
Expiring < 6mo
0
Expired
21
Basic UDI-DIs
74
Devices
417
Manufacturers
22
Cert. Types
6
Basic Information
- Address
- Am TÜV 1, 45307 Essen, Germany
- [email protected]
- Phone
- +49 (0) 201 825-0
- Website
- www.tuev-nord-cert.de
Regulatory Overview
Regulation
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Eu Mdd
67
Eu Mdr
7
Classification
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Eu Md Class 2b
38
Eu Md Class 2a
24
Eu Md Class 1
8
Eu Md Class 3
4
Device Types
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Certificate Health
Total
27
Valid
2
Expiring < 6mo
0
Expired / Withdrawn
21
Certificates by Expiry Year
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| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| MDD Annex V | 04235060302 | BojongMC Co.,Ltd. | Feb 27, 2023 | |||
| MDD Annex II (excluding section 4) | 44232117851 | Cutera, Inc. | Apr 15, 2023 | |||
| MDD Annex II (excluding section 4) | 44 232 066844 | ELECTRODYNAMICS MANUFACTURING Ltd | Oct 15, 2023 | |||
| MDD Annex II (excluding section 4) | 44232066844 | ELECTRODYNAMICS MANUFACTURING Ltd | Oct 15, 2023 | |||
| MDD Annex II (excluding section 4) | 44232121827 | Si-tec GmbH Dental-Spezialartikel | Dec 03, 2023 | |||
| MDD Annex II (excluding section 4) | 44232200504 | Iolution GmbH | Mar 31, 2024 | |||
| MDD Annex II (excluding section 4) | 44232171265 | UPM-Kymmene Corporation | May 13, 2024 | |||
| MDD Annex II (excluding section 4) | 44232160752 | Heyer Benelux NV | May 21, 2024 | |||
| MDD Annex V | 44235200238 | Purenum GmbH | May 24, 2024 | |||
| MDD Annex V | 44235190744 | iSEKS diagnostics GmbH | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 44 232 127899 | View-M Technology | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 44232191996 | Scholz Medical GmbH | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 44 232 117847 | POTEC Co., Ltd. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 44232121392 | Rovers Medical Devices B.V. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 35274334 | VOSTRA GmbH | May 26, 2024 | |||
| MDD Annex II Section 4 | 35288663 | VOSTRA GmbH | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 44232117836 | Yelatma Instrument-Making Enterprise Joint-Stock Company | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 44232160652 | EVER Neuro Pharma GmbH | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 4432141009 | Luxxamed GmbH | May 26, 2024 | |||
| MDD Annex III | 0815 | VOSTRA GmbH | Jun 24, 2024 | |||
| MDD Annex II (excluding section 4) | 44232121441 | Moeck & Moeck GmbH | Dec 31, 2024 | |||
| MDR QMS | 44911221524 | Preventicus GmbH | MDR | Jul 2023 | Jul 26, 2028 | Issued |
| MDD Annex II (excluding section 4) | 44232160605 | P.G.F. Industry Solutions GmbH | Dec 31, 2028 | |||
| MDD Annex II (excluding section 4) | 44232191996 | Scholz Medical GmbH | Dec 31, 2028 | |||
| MDR Technical Documentation | 44912221174 | Rontis Corporation SA | MDR | Mar 2024 | Mar 14, 2029 | Issued |
| MDR Technical Documentation | 3535 3794 | Hager & Meisinger GmbH | — | |||
| MDR Technical Documentation | 44912221174 | Rontis Corporation SA | — |
Manufacturer Portfolio
| Manufacturer | Certificates | |||
|---|---|---|---|---|
| VOSTRA GmbH | 🇩🇪 Germany | 3 | 0 | 0 |
| Rontis Corporation SA | 🇨🇭 Switzerland | 2 | 1 | 0 |
| ELECTRODYNAMICS MANUFACTURING Ltd | 2 | 0 | 0 | |
| Scholz Medical GmbH | 🇩🇪 Germany | 2 | 0 | 0 |
| Luxxamed GmbH | 🇩🇪 Germany | 1 | 0 | 0 |
| UPM-Kymmene Corporation | 🇫🇮 Finland | 1 | 0 | 0 |
| EVER Neuro Pharma GmbH | 🇦🇹 Austria | 1 | 0 | 0 |
| Yelatma Instrument-Making Enterprise Joint-Stock Company | 🇷🇺 Russian Federation | 1 | 0 | 0 |
| Si-tec GmbH Dental-Spezialartikel | 🇩🇪 Germany | 1 | 0 | 0 |
| Rovers Medical Devices B.V. | 🇳🇱 Netherlands | 1 | 0 | 0 |
| POTEC Co., Ltd. | 🇰🇷 South Korea | 1 | 0 | 0 |
| Purenum GmbH | 🇩🇪 Germany | 1 | 0 | 0 |
| Heyer Benelux NV | 🇧🇪 Belgium | 1 | 0 | 0 |
| View-M Technology | 🇰🇷 South Korea | 1 | 0 | 0 |
| BojongMC Co.,Ltd. | 🇰🇷 South Korea | 1 | 0 | 0 |
| Moeck & Moeck GmbH | 🇩🇪 Germany | 1 | 0 | 0 |
| Iolution GmbH | 🇩🇪 Germany | 1 | 0 | 0 |
| Cutera, Inc. | 🇺🇸 United States | 1 | 0 | 0 |
| iSEKS diagnostics GmbH | 🇩🇪 Germany | 1 | 0 | 0 |
| P.G.F. Industry Solutions GmbH | 🇦🇹 Austria | 1 | 0 | 0 |
| Hager & Meisinger GmbH | 🇩🇪 Germany | 1 | 0 | 0 |
| Preventicus GmbH | 🇩🇪 Germany | 1 | 1 | 0 |