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Single-use Choledochoscope
EUDAMEDClass IIa (EU MDR)
Ref PCH22-3Model 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, PCH24-6Ref PCH12-2Ref PCH22-4Ref PCH24-5Ref PCH24-1Ref PCH24-2Ref PCH24-6Ref PCH24-4Ref PCH22-6Ref PCH22-1Ref PCH22-5Ref PCH22-2
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 EUDAMEDPCH22-3 EUDAMEDPCH12-2 EUDAMEDPCH22-4 EUDAMEDPCH24-5 EUDAMEDPCH24-1 EUDAMEDPCH24-2 EUDAMEDPCH24-6 EUDAMEDPCH24-4 EUDAMEDPCH22-6 EUDAMEDPCH22-1 EUDAMEDPCH22-5 EUDAMEDPCH22-2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975202777385 EUDAMED06975202777347 EUDAMED06975202777392 EUDAMED06975202773387 EUDAMED06975202772892 EUDAMED06975202773332 EUDAMED06975202773394 EUDAMED06975202773356 EUDAMED06975202773325 EUDAMED06975202777361 EUDAMED06975202773318 EUDAMED06975202777378 EUDAMED
- Basic UDI-DI
- 697520277YS015LC EUDAMED
- Direct Marketing DI
- 06975202777385 EUDAMED06975202777347 EUDAMED06975202777392 EUDAMED06975202773387 EUDAMED06975202772892 EUDAMED06975202773332 EUDAMED06975202773394 EUDAMED06975202773356 EUDAMED06975202773325 EUDAMED06975202777361 EUDAMED06975202773318 EUDAMED06975202777378 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 (12)
- EUDAMED 64e27129-b77e-4983-aff7-c39b55225f28 61 fields · synced Sep 18, 2026
- EUDAMED 943d1e70-24da-48da-8275-732b466a0108 61 fields · synced May 16, 2026
- EUDAMED 71b5277d-a905-493c-8fe0-8c7ed0a2882c 61 fields · synced May 16, 2026
- EUDAMED f16263ce-27a5-46da-8ea7-a14469f856ee 61 fields · synced May 16, 2026
- EUDAMED d2b9f9de-fe27-4c25-aa8d-b8ca48ccc31c 61 fields · synced May 17, 2026
- EUDAMED 2c2c7829-c669-4ca8-b89e-422ea113e42e 61 fields · synced May 17, 2026
- EUDAMED f2a6f356-2cd9-4821-9a78-371acba3a1e6 61 fields · synced May 17, 2026
- EUDAMED 4b219b41-6941-4bc1-aa81-f230155a3f3c 61 fields · synced May 17, 2026
- EUDAMED 303bb2af-b9a4-4912-a955-35f5266498a4 61 fields · synced May 17, 2026
- EUDAMED cfae55cb-1082-47fb-958a-5172a31366a6 61 fields · synced May 18, 2026
- EUDAMED d236bc50-1323-4f1f-9186-313b06272848 61 fields · synced May 18, 2026
- EUDAMED bbed2387-ba7f-455e-8756-a8aca5969119 61 fields · synced May 18, 2026