Identity
- Trade Name
- 3D Video Endoscope EUDAMED
- Device Name
- 3D Video Endoscope EUDAMED
- Model / Reference
- TUL-E3010K EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974439671381 EUDAMED
- Basic UDI-DI
- 6974439673026F4 EUDAMED
- Direct Marketing DI
- 06974439671381 EUDAMED
- EMDN Code
- Z12029016 VIDEO LAPAROSCOPES EUDAMED
Classification
- Device Class
- Class IIa 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
3D Video Endoscope by Nanjing Tuge Healthcare Co., Ltd. — Class IIa — 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 | 6974439673026F4 | Class IIa | 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 7e562563-4ac3-46cf-b0ea-aaf9e7de7c2c 61 fields · synced Oct 5, 2026