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neoBLUE blanket Large Disposable Mattress Cover (package of 50)
EUDAMEDClass IIa (EU MDR)
Ref 005989Model neoBLUE blanket LED Phototherapy System
Identity
- Trade Name
- neoBLUE blanket Large Disposable Mattress Cover (package of 50) EUDAMED
- Device Name
- neoBLUE blanket LED Phototherapy System EUDAMED
- Model / Reference
- neoBLUE blanket LED Phototherapy System EUDAMED005989 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05713315011849 EUDAMED
- Basic UDI-DI
- 5713315NA000204W EUDAMED
- EMDN Code
- Z12080401 PAEDIATRIC PHOTOTHERAPY EQUIPMENT EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Denmark 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
neoBLUE blanket Large Disposable Mattress Cover (package of 50) by Natus Medical Denmark ApS — Class IIa — MDR — listed in EUDAMED
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 | 5713315NA000204W | Class IIa | Active |
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Manufacturer
- Manufacturer
- Natus Medical Denmark ApS
- EUDAMED SRN
- DK-MF-000001617
Sources (1)
- EUDAMED 0ac3b686-ccc2-4ee5-a94a-e1062aa3c11a 61 fields · synced Jun 19, 2026