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neoBLUE nova

by Natus Medical Denmark ApS

Ref 018213Model neoBLUE nova

neoBLUE nova (018213) is an overhead infant phototherapy unit (EU MDR Class IIa; FDA Class II; FDA product code LBI, Unit, Neonatal Phototherapy) made by Natus Medical Denmark ApS, registered in EUDAMED on 16 Oct 2025 (Basic UDI-DI 5713315TA000017Y), cleared under FDA 510(k) K160745 on 12 Dec 2016 and listed in FDA GUDID since 27 May 2025 (UDI-DI 05713315011214), active (EUDAMED, FDA 510(k)), not in commercial distribution (GUDID) as of 22 Oct 2026.

Active European Union and United States. Also listed in GUDID (US), not in commercial distribution.

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K160745

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number5713315TA000017Y Basic UDI-DI 05713315011214UDI-DIDate16 Oct 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number05713315011214 UDI-DI Date27 May 2025ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK160745 Date12 Dec 2016DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 5713315TA000017Y registered 16 Oct 2025 Active
  • FDA 510(k) K160745 decided 12 Dec 2016 Active
  • FDA GUDID UDI-DI 05713315011214 listed 27 May 2025 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K160745
  2. Listed FDA GUDID 05713315011214
  3. Registered EUDAMED 5713315TA000017Y

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Generic name
Overhead infant phototherapy unit
Model / Ref / Catalog
neoBLUE nova, 018213
Primary DI / UDI-DI
05713315011214
Basic UDI-DI
5713315TA000017Y
Direct marketing DI
05713315011214
510(k) Number
FDA product code
LBI
EMDN code
Z12080401 Paediatric phototherapy equipment
GMDN term
Overhead infant phototherapy unit
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
880.5700
System or procedure pack
System which is a device in itself
EU registration type
Standard device
EU market of registration
Denmark
GUDID distribution status
Not in Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN
DK-MF-000001617

Similar devices in this category

Other devices filed under PAEDIATRIC PHOTOTHERAPY EQUIPMENT.

Other devices from Natus Medical Denmark ApS

See all devices from Natus Medical Denmark ApS →

Properties

  • Reusable
  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (21, all answered No)