Single-use Choledochoscope
by Hunan Endoso Life Technology Co., Ltd 4 variants
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
Single-use Choledochoscope (PCH24-3) is a medical device (EU MDR Class IIa; EMDN category video choledocoscopes) made by Hunan Endoso Life Technology Co., Ltd, registered in EUDAMED on 25 Nov 2025 (Basic UDI-DI 697520277YS015LC) with CE/MDR certificate 6124105CE01 valid until 1 Nov 2029, active as of 23 Oct 2026.
Active
Valid until
1 Nov 2029
FDA recalls
Not applicable
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number6124105CE01 | Date2 Oct 2026 | StatusActive |
Official records
- EUDAMED public site 697520277YS015LC
Certificates
- 6124105CE01 Active
Quality management system EU MDR
- Certifier
- DEKRA Certification B.V. 0344
- Issued
- 20 Apr 2026
- Expires
- 1 Nov 2029
- Reason
- Mnf ar change
- 6124105CE01 Active
Quality management system EU MDR
- Certifier
- DEKRA Certification B.V. 0344
- Issued
- 2 Oct 2026
- Expires
- 1 Nov 2029
- Reason
- Add device or group
Timeline
- Registered EUDAMED 697520277YS015LC
- Certificate issued EUDAMED 6124105CE01
- Certificate expires EUDAMED 6124105CE01
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device name
- Single-use Choledochoscope
- 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
- Primary DI / UDI-DI
- 06975202773349
- Basic UDI-DI
- 697520277YS015LC
- Direct marketing DI
- 06975202773349
- EMDN code
- Z12020507 Video choledocoscopes
- Device class
- Class IIa
- System or procedure pack
- Procedure pack which is a device in itself
- EU registration type
- Standard device
- EU market of registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- CN-MF-000021400
- Authorised representative
- Umedwings Netherlands B.V. NL-AR-000000444
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