Identity
- Trade Name
- Neonatal Phototherapy Eye Mask EUDAMED
- Device Name
- Neonatal Phototherapy Eye Mask EUDAMED
- Model / Reference
- UBE-L01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936735487837 EUDAMED
- Basic UDI-DI
- 69456648UNEP4N EUDAMED
- EMDN Code
- V0201 PHOTOTHERAPY MASKS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland 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
Category: Phototherapy eye protector, reusable
Neonatal Phototherapy Eye Mask by Unimed Medical Supplies, Inc. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 69456648UNEP4N | Class I | Active |
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Manufacturer
- Manufacturer
- Unimed Medical Supplies, Inc
- EUDAMED SRN
- CN-MF-000001480
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED a6c43148-a81b-4df9-9071-42a0dbb8a9e4 61 fields · synced Jul 23, 2026