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Single-use Choledochoscope
EUDAMEDClass IIa (EU MDR)
Ref PCH24-3Model PCH12-1, PCH12-2, PCH12-3, PCH22-1, PCH22-2, PCH22-3, PCH22-4, PCH22-5, PCH22-6, PCH24-1, PCH24-2, PCH24-3, PCH24-4, PCH24-5, PCH24-6
Identity
- Device Name
- Single-use Choledochoscope EUDAMED
- Model / Reference
- PCH12-1, PCH12-2, PCH12-3, PCH22-1, PCH22-2, PCH22-3, PCH22-4, PCH22-5, PCH22-6, PCH24-1, PCH24-2, PCH24-3, PCH24-4, PCH24-5, PCH24-6 EUDAMEDPCH24-3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975202773349 EUDAMED
- Basic UDI-DI
- 697520277YS015LC EUDAMED
- Direct Marketing DI
- 06975202773349 EUDAMED
- EMDN Code
- Z12020507 VIDEO CHOLEDOCOSCOPES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands 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 Choledochoscope by Hunan Endoso Life 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 | 697520277YS015LC | Class IIa | Active |
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Manufacturer
- Manufacturer
- Hunan Endoso Life Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000021400
- Authorised Representative
- Umedwings Netherlands B.V. NL-AR-000000444
Sources (1)
- EUDAMED 51d97ff6-f8df-4d58-bb83-e3444dd49463 61 fields · synced Jun 18, 2026