Identity
- Trade Name
- Magnetic Prism - 8 Diopter EUDAMED
- Device Name
- Prism EUDAMED
- Model / Reference
- 11201-8 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +B0911120180W 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
Magnetic Prism - 8 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 |
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Manufacturer
- Manufacturer
- Gulden Ophthalmics
- EUDAMED SRN
- US-MF-000008608
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (1)
- EUDAMED a9c8fa87-8801-4c82-b681-ac101f398d6b 61 fields · synced Jun 20, 2026