Identity
- Trade Name
- Eye Shield, Adult (Bulk) EUDAMED
- Device Name
- Eye Shields EUDAMED
- Model / Reference
- 14100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +B091141001Q EUDAMED
- Basic UDI-DI
- ++B091EyeShieldsZA EUDAMED
- Unit of Use DI
- +B091141000P EUDAMED
- EMDN Code
- M040399 OPHTHALMIC DRESSINGS - 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
Eye Shield, Adult (Bulk) 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 | ++B091EyeShieldsZA | 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 480c398b-6785-4d6e-a98e-f5cd70e13d70 61 fields · synced Jun 20, 2026