Identity
- Trade Name
- Endoscopic Imaging System EUDAMED
- Device Name
- Endoscopic Imaging System EUDAMED
- Model / Reference
- TDE-V420X EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974439672210 EUDAMED
- Basic UDI-DI
- 6974439671909G3 EUDAMED
- Direct Marketing DI
- 06974439672210 EUDAMED
- EMDN Code
- Z12020405 SURGICAL CAMERAS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Endoscopic Imaging System by Nanjing Tuge Healthcare Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 6974439671909G3 | Class I | Active |
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Manufacturer
- Manufacturer
- Nanjing Tuge Healthcare Co., Ltd.
- EUDAMED SRN
- CN-MF-000018925
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (1)
- EUDAMED 7493cde7-bf37-42a5-884a-4d1ea3e17b26 61 fields · synced Oct 6, 2026