Identity
- Trade Name
- Video Enteroscope UEN-400I EUDAMED
- Device Name
- Video Enteroscope EUDAMED
- Model / Reference
- UEN-400I EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973519704384 EUDAMED
- Basic UDI-DI
- 697351970UEN0001T4 EUDAMED
- Direct Marketing DI
- 06973519704384 EUDAMED
- EMDN Code
- Z12020607 VIDEO ENTEROSCOPES 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
Video Enteroscope UEN-400I by Shanghai Aohua Photoelectricity Endoscope 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 | 697351970UEN0001T4 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shanghai Aohua Photoelectricity Endoscope Co., Ltd.
- EUDAMED SRN
- CN-MF-000030035
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 2abebef7-e2d6-4a53-b494-665a5fe88d72 61 fields · synced Oct 8, 2026