Identity
- Trade Name
- Neonatal Phototherapy Bed EUDAMED
- Model / Reference
- BL20 EUDAMEDBL20B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06945429062038 EUDAMED
- Basic UDI-DI
- 69454290BL002JB EUDAMED
- EMDN Code
- Z12080401 PAEDIATRIC PHOTOTHERAPY EQUIPMENT EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Ireland 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 Bed by Shenzhen Comen Medical Instruments Co., LTD. — Class IIa — 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 | 69454290BL002JB | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shenzhen Comen Medical Instruments Co., LTD.
- EUDAMED SRN
- CN-MF-000002236
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED b839634c-ef57-4da3-b234-5c7144ece39c 61 fields · synced Oct 6, 2026