Medical Endoscopic Fluorescence Cold Light Source
by Weyo Surgical Technology Ltd. EUDAMED
Active
Ref wMizar F10pModel wMizar F10u, wMizar F10p, wMizar F10g, wMizar F10s, wMizar F10e, wMizar F10b
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697562167Z12020402028E | Date12 Aug 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Device Name
- Medical Endoscopic Fluorescence Cold Light Source
- Model / Reference
- wMizar F10u, wMizar F10p, wMizar F10g, wMizar F10s, wMizar F10e, wMizar F10b, wMizar F10p
- Primary DI / UDI-DI
- 06975621670526
- Basic UDI-DI
- 697562167Z12020402028E
- EMDN Code
- Z12020402 Light sources for endoscopy and minimally invasive surgery
- Device Class
- Class I
- Market of Registration
- Ireland
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 (13)
- Sterile: No
- Implantable: No
- Reusable: 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