4K Medical Endoscopic Fluorescence Camera System
by Weyo Surgical Technology Ltd. EUDAMED
Active
Ref wMerak F40eModel wMerak F40u wMerak F40p wMerak F40a wMerak F40g wMerak F40s wMerak F40e wMerak F40c wMerak F40b
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697562167Z12020401038B | 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- Withdrawn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
- 4K Medical Endoscopic Fluorescence Camera System
- Model / Reference
- wMerak F40u wMerak F40p wMerak F40a wMerak F40g wMerak F40s wMerak F40e wMerak F40c wMerak F40b, wMerak F40e
- Primary DI / UDI-DI
- 06975621670502
- Basic UDI-DI
- 697562167Z12020401038B
- EMDN Code
- Z12020401 Integrated systems for the acquisition and management of endoscopic and minimally invasive surgery images
- 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