nun
Ref 08800065600007, 08800065600014Model WFE-02S, WFC-01
nun (08800065600007) is a Class I device made by WikiOptics Inc., registered in EUDAMED on 31 Dec 2024 (Basic UDI-DI 08800065600007H6), active as of 7 Nov 2026.
Active
CE MDR
Valid until
No date given
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number08800065600007H6 | Date31 Dec 2024 | StatusActive |
Official records
- EUDAMED public site 08800065600007H6
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- Withdrawn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
- OphthalmoscopeFundus Camera
- Model / reference
- WFE-02S, 08800065600007, WFC-01, 08800065600014
- Primary DI / UDI-DI
- 08800065600007, 08800065600014
- Basic UDI-DI
- 08800065600007H6, 8800065600014XH
- EMDN code
- Z12120114, Z12120199
- Device class
- Class I
- System or procedure pack
- System which is a device in itself
- EU registration type
- Standard device
- EU market of registration
- PolandSpain
Manufacturer details
- EUDAMED SRN
- KR-MF-000026369
- Authorised representative
- Javitech Consulting GmbH DE-AR-000045915
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