Versa
by PENTAX-Aohua Medical Technologies Co., Ltd. China EUDAMED
Ref EC38-V10cMModel EC38-V10cM, EC38-V10cL, EC38-V12cM, EC38-V12cL
EMDN Z12020606
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | Number697227211ECXD | Date19 May 2026 | StatusActive |
| European Union | CE/MDR | Number697227211ECXD | Date19 May 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDD, CE/MDR Active
Specification
- Device Name
- PENTAX Medical Video Colonoscope
- Model / Reference
- EC38-V10cM, EC38-V10cL, EC38-V12cM, EC38-V12cL
- Primary DI / UDI-DI
- 06972272110036
- Basic UDI-DI
- 697227211ECXD, B-06972272110036
- Direct Marketing DI
- 06972272110036
- EMDN Code
- Z12020606 Video colonoscopes
- Device Class
- Class IIa
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000005686
- Authorised representative
- PENTAX Europe GmbH DE-AR-000000006
Other devices from PENTAX-Aohua Medical Technologies Co., Ltd.
Properties & raw data
Show properties, registry sources and raw records
Other properties (12)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
Sources (2)
- EUDAMED 33db9fad-c17f-49ff-99d6-64d853bdfae2
- EUDAMED 06972272110036|B-06972272110036