4K Medical Endoscopic Fluorescence Camera System
by Weyo Surgical Technology Ltd. 8 variants
Ref wMerak F40uModel wMerak F40u wMerak F40p wMerak F40a wMerak F40g wMerak F40s wMerak F40e wMerak F40c wMerak F40b
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697562167Z12020401038B 06975621670458 | Date12 Aug 2026 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
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 F40u
- Primary DI / UDI-DI
- 06975621670458
- 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
- EU market of registration
- Netherlands
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