Identity
- Trade Name
- NeoBLUE Nova FDA UDI
- Generic Name
- Overhead infant phototherapy unit FDA UDI
- Device Name
- neoBLUE nova EUDAMEDneoBLUE nova LED Phototherapy System, US power cord FDA UDI
- Model / Reference
- neoBLUE nova EUDAMED018213 EUDAMEDFDA UDI
- Description
- neoBLUE nova LED Phototherapy System, US power cord FDA UDI
Identifiers
- Catalog Number
- 018213 FDA UDI
- Primary DI / UDI-DI
- 05713315011214 EUDAMEDFDA UDI
- Basic UDI-DI
- 5713315TA000017Y EUDAMED
- Direct Marketing DI
- 05713315011214 EUDAMED
- 510(k) Number
- K160745 FDA UDI
- FDA Product Code
- LBI FDA UDI
- EMDN Code
- Z12080401 PAEDIATRIC PHOTOTHERAPY EQUIPMENT EUDAMED
- GMDN Term
- Overhead infant phototherapy unit FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 880.5700 FDA UDI
- Market of Registration
- Denmark EUDAMED
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
neoBLUE nova by Natus Medical Denmark ApS — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 5713315TA000017Y | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Natus Medical Denmark ApS
- EUDAMED SRN
- DK-MF-000001617
Sources (2)
- EUDAMED 17aa7c93-7e43-472a-ad88-e6383c23fb41 61 fields · synced Jul 22, 2026
- FDA UDI e91609b7-9b6b-44a6-bd8d-50a9cbe1b5d9 36 fields · synced May 30, 2026