Medical Endoscopic Fluorescence Cold Light Source
by Weyo Surgical Technology Ltd. EUDAMED
Active
Ref wMizar F10eModel 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- Withdrawn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
EU market availability
Made available in 32 countries, as listed in EUDAMED:
- Austria since 12 Aug 2026
- Belgium since 12 Aug 2026
- Bulgaria since 12 Aug 2026
- Croatia since 12 Aug 2026
- Cyprus since 12 Aug 2026
- Czechia since 12 Aug 2026
- Denmark since 12 Aug 2026
- Estonia since 12 Aug 2026
- Finland since 12 Aug 2026
- France since 12 Aug 2026
- Germany since 12 Aug 2026
- Greece since 12 Aug 2026
- Hungary since 12 Aug 2026
- Iceland since 12 Aug 2026
- Ireland since 12 Aug 2026
- Italy since 12 Aug 2026
- Latvia since 12 Aug 2026
- Liechtenstein since 12 Aug 2026
- Lithuania since 12 Aug 2026
- Luxembourg since 12 Aug 2026
- Malta since 12 Aug 2026
- Netherlands since 12 Aug 2026
- Northern Ireland since 12 Aug 2026
- Norway since 12 Aug 2026
- Poland since 12 Aug 2026
- Portugal since 12 Aug 2026
- Romania since 12 Aug 2026
- Slovakia since 12 Aug 2026
- Slovenia since 12 Aug 2026
- Spain since 12 Aug 2026
- Sweden since 12 Aug 2026
- Türkiye since 12 Aug 2026
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 F10e
- Primary DI / UDI-DI
- 06975621670557
- 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