Medical Endoscopic LED Cold Light Source
by Weyo Surgical Technology Ltd. 10 variants
Ref wMizar 10cModel wMizar 10u、wMizar 10p、wMizar 10a、wMizar 10c、wMizar V10A、wMizar V10B、wMizar V10C、 wMizar V10D、wMizar V10E、wMizar V10F
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697562167Z12020402018C 06975621670120 | Date27 Aug 2025 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- wMizar 10u、wMizar 10p、wMizar 10a、wMizar 10c、wMizar V10A、wMizar V10B、wMizar V10C、 wMizar V10D、wMizar V10E、wMizar V10F, wMizar 10c
- Primary DI / UDI-DI
- 06975621670120
- Basic UDI-DI
- 697562167Z12020402018C
- EMDN Code
- Z12020402 Light sources for endoscopy and minimally invasive surgery
- Device Class
- Class I
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000038773
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Weyo Surgical Technology Ltd.
Properties
Other properties (12)
- Sterile: No
- Implantable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No