Identity
- Trade Name
- Neonatal Phototherapy Eye Mask EUDAMED
- Device Name
- Neonatal Phototherapy Eye Mask EUDAMED
- Model / Reference
- UBE-S01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936735487820 EUDAMED
- Basic UDI-DI
- 69456648UNEP4N EUDAMED
- EMDN Code
- V0201 PHOTOTHERAPY MASKS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Czechia 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
Neonatal Phototherapy Eye Mask by Unimed Medical Supplies, Inc. — 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 | 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 af0299b6-4140-4ea6-9800-c1f59f08beb9 61 fields · synced Jul 11, 2026