Stick Prism - 50 Diopter
by Gulden Ophthalmics EUDAMED
Active
Ref 11104-50
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number++B091PrismsTY | Date18 May 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- 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
- Prism
- Model / Reference
- 11104-50
- Primary DI / UDI-DI
- +B09111104500V
- Basic UDI-DI
- ++B091PrismsTY
- EMDN Code
- Z12120299 Therapeutic and surgical ophtholmological treatments instruments - other
- Device Class
- Class I
- Market of Registration
- Belgium
Manufacturer details
- EUDAMED SRN
- US-MF-000008608
- Authorised representative
- QbD RepS BV BE-AR-000000040
Other devices from Gulden Ophthalmics
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