Penlight
by Keeler Ltd
Ref 1602-P-1080
Penlight (1602-P-1080) is a medical device (EU MDR Class I) made by Keeler Ltd, registered in EUDAMED on 28 Oct 2026 (Basic UDI-DI 50552727PENLIGHT22), 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 | Number50552727PENLIGHT22 05055272711234 | Date28 Oct 2026 | StatusActive |
Official records
- EUDAMED public site 50552727PENLIGHT22
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- Withdrawn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
- Penlight
- Model / reference
- 1602-P-1080
- Primary DI / UDI-DI
- 05055272711234
- Basic UDI-DI
- 50552727PENLIGHT22
- EMDN code
- Z12120180 Ophtalmology assessments and diagnosis instruments - hardware accessories
- Device class
- Class I
- EU registration type
- Standard device
- EU market of registration
- Cyprus
Manufacturer details
- EUDAMED SRN
- GB-MF-000009031
- Authorised representative
- Keeler Europe Distribution, S.L. ES-AR-000001559
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