Identity
- Device Name
- Single-use Video Choledochoscope EUDAMED
- Model / Reference
- SCH-200 EUDAMED/ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06953393135016 EUDAMED
- Basic UDI-DI
- 69533931CH20SKW EUDAMED
- EMDN Code
- Z12020507 VIDEO CHOLEDOCOSCOPES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
Yes
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
Single-use Video Choledochoscope by HUGER Medical Instrument 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 | 69533931CH20SKW | Class IIa | Active |
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Manufacturer
- Manufacturer
- HUGER Medical Instrument Co., Ltd.
- EUDAMED SRN
- CN-MF-000001128
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED ba84af05-29b5-4cf8-884e-23b5f06a019c 61 fields · synced Jun 19, 2026