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Single Use Flexible Video Choledochoscope
EUDAMEDClass IIa (EU MDR)
Ref PCH111-S (Standard Deflection)Model PCH100-S, PCH111-S
Identity
- Device Name
- Single Use Flexible Video Choledochoscope EUDAMED
- Model / Reference
- PCH100-S, PCH111-S EUDAMEDPCH111-S (Standard Deflection) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971176280883 EUDAMED
- Basic UDI-DI
- 697117628GDS 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 Flexible Video Choledochoscope by Zhuhai Pusen Medical Technology 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 | 697117628GDS | Class IIa | Active |
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Manufacturer
- Manufacturer
- Zhuhai Pusen Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000009220
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED af8d58ad-5bf8-4594-8d34-9b5ea50fc374 61 fields · synced May 29, 2026