Identity
- Trade Name
- Single Prism - 10 Diopter EUDAMED
- Device Name
- Prism EUDAMED
- Model / Reference
- 11101-10 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +B09111101100O EUDAMED
- Basic UDI-DI
- ++B091PrismsTY EUDAMED
- EMDN Code
- Z12120299 THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Single Prism - 10 Diopter by Gulden Ophthalmics — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++B091PrismsTY | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Gulden Ophthalmics
- EUDAMED SRN
- US-MF-000008608
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (1)
- EUDAMED a5cb8d3f-4bcc-4061-a7c2-62e8645db68c 61 fields · synced Aug 4, 2026