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Lullaby LED Phototherapy System

by Datex-Ohmeda Inc.

Ref 2052663-001

Lullaby LED Phototherapy System is an overhead infant phototherapy unit (EU MDR Class IIa; FDA Class II; FDA product code LBI, Unit, Neonatal Phototherapy) made by Datex-Ohmeda Inc., registered in EUDAMED on 1 Jun 2026 (Basic UDI-DI 8406821BUG00395HY) and listed in FDA GUDID since 24 Jun 2016 (UDI-DI 00840682117401), active as of 23 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number8406821BUG00395HY Basic UDI-DI 00840682117401UDI-DIDate1 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00840682117401 UDI-DI Date24 Jun 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 8406821BUG00395HY registered 1 Jun 2026 Active
  • FDA GUDID UDI-DI 00840682117401 listed 24 Jun 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00840682117401
  2. Registered EUDAMED 8406821BUG00395HY

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Lullaby LED Phototherapy System EUDAMED
Lullaby GUDID
Generic name
Overhead infant phototherapy unit
Model / reference
2052663-001 EUDAMED
LED Phototherapy System GUDID
Primary DI / UDI-DI
00840682117401
Basic UDI-DI
8406821BUG00395HY
Direct marketing DI
00840682117401
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
EU registration type
Standard device
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
2052663-001
GUDID
LED Phototherapy System
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.

Related devices

Category: Overhead infant phototherapy unit

Similar devices in this category

Other devices filed under PAEDIATRIC PHOTOTHERAPY EQUIPMENT.

Other devices from Datex-Ohmeda Inc.

See all devices from Datex-Ohmeda Inc. →

Properties

  • Prescription use
  • Serial number
Other properties (23, all answered No)