← Back to catalogue
neoBLUE blanket LED Phototherapy System Light Box with power supply
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref 024738Model neoBLUE blanket LED Phototherapy System
Identity
- Trade Name
- neoBLUE blanket LED Phototherapy System Light Box with power supply EUDAMED
- Device Name
- neoBLUE blanket LED Phototherapy System EUDAMED
- Model / Reference
- neoBLUE blanket LED Phototherapy System EUDAMED024738 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05713315011405 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 LED Phototherapy System Light Box with power supply by Natus Medical Denmark ApS — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K182178 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K103589 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 5713315NA000204W | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Natus Medical Denmark ApS
- EUDAMED SRN
- DK-MF-000001617
Sources (2)
- EUDAMED 122d4387-50db-4c7d-a038-1157441cd30c 61 fields · synced Jul 20, 2026
- FDA 510(k) K182178 1 fields · synced May 18, 2026