Identity
- Trade Name
- Cornea Silicone Light Shield, blue EUDAMED
- Device Name
- Reusable Eye Shields (Corneal Shields) EUDAMED
- Model / Reference
- 99441Y1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04058935009960 EUDAMED
- Basic UDI-DI
- B-04058935009960 EUDAMED
- EMDN Code
- Q029003 CORNEAL PROTECTION MECHANICAL DEVICES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Cornea Silicone Light Shield, blue by Bausch & Lomb GmbH — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04058935009960 | Class I | Active |
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Manufacturer
- Manufacturer
- Bausch & Lomb GmbH
- EUDAMED SRN
- DE-MF-000009142
Sources (1)
- EUDAMED 36d788a6-84ae-42aa-8cf4-f9d06066ca6d 61 fields · synced Jul 29, 2026