Endoscopic Image Processor
by Hunan Endoso Life Technology Co., Ltd 3 variants
Ref P1-EModel P1-A、P1-B、P1-C、P1-D、P1-E、P2-A、P2-B、P2-C、P2-D、P2-E
Endoscopic Image Processor (P1-E) is a medical device (EU MDR Class IIa; EMDN category video processors) made by Hunan Endoso Life Technology Co., Ltd, registered in EUDAMED on 24 Jan 2025 (Basic UDI-DI 697520277010HY) with CE/MDR certificate 6124105CE01 valid until 1 Nov 2029, active as of 24 Oct 2026.
Active
CE MDR
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 697520277010HY
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 697520277010HY
- Certificate issued EUDAMED 6124105CE01
- Certificate expires EUDAMED 6124105CE01
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device name
- Endoscopic Image Processor
- Model / reference
- P1-A、P1-B、P1-C、P1-D、P1-E、P2-A、P2-B、P2-C、P2-D、P2-E, P1-E
- Primary DI / UDI-DI
- 06975202772991
- Basic UDI-DI
- 697520277010HY
- Direct marketing DI
- 06975202772991
- EMDN code
- Z12020406 Video processors
- 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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