The Frisby Screener Pocket Stereotest (2 Plates)
Ref FPS-2PModel FPS2P
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 | Number50700039007FPS2PGJ 05070003900725 | Date11 May 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- Withdrawn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
- Model / Reference
- FPS2P, FPS-2P
- Primary DI / UDI-DI
- 05070003900725
- Basic UDI-DI
- 50700039007FPS2PGJ
- EMDN Code
- Q0299 Ophthalmic devices - other
- Device Class
- Class I
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- UK-MF-000048319
- Authorised representative
- Comply Express Lda PT-AR-000004357
From the manufacturer
Manufacturer's product page: Frisby Screener Pocket Stereotest - 2 Plates
Other devices from Stereotest Limited
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