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bili-hut

by Little Sparrows Technologies, Inc.

Ref 0130AModel bili-hut

bili-hut (0130A) is an overhead infant phototherapy unit (EU MDR Class IIa; FDA Class II; FDA product code LBI, Unit, Neonatal Phototherapy) made by Little Sparrows Technologies, Inc., registered in EUDAMED on 18 Mar 2025 (Basic UDI-DI 0810101280130JG) with CE/MDR certificate 44911230411 valid until 11 Mar 2030, cleared under FDA 510(k) K190899 on 5 Sep 2019 and listed in FDA GUDID since 10 Mar 2022 (UDI-DI 00810101280405), active as of 22 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

11 Mar 2030

CE MDR certificate

FDA recalls

None found

in data synced 22 Oct 2026

Documents

1 certificate

Certifier TÜV NORD CERT GmbH

510(k) K190899

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 Number0810101280130JG Basic UDI-DI 00810101280405UDI-DIDate18 Mar 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00810101280405 UDI-DI Date10 Mar 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) GUDID from GUDID NumberK190899 Date5 Sep 2019IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0810101280130JG registered 18 Mar 2025 Active· +1 more in the status table
  • FDA 510(k) K190899 decided 5 Sep 2019 Active
  • FDA GUDID UDI-DI 00810101280405 listed 10 Mar 2022 Listed

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 44911230411 Active

    Quality management system EU MDR

    Certifier
    TÜV NORD CERT GmbH 0044
    Issued
    12 Mar 2025
    Expires
    11 Mar 2030

Timeline

5 dated events

  1. Cleared FDA 510(k) K190899
  2. Listed FDA GUDID 00810101280405
  3. Certificate issued EUDAMED 44911230411
  4. Registered EUDAMED 0810101280130JG
  5. Certificate expires EUDAMED 44911230411

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  • Withdrawn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 / reference
bili-hut, 0130A
Primary DI / UDI-DI
00810101280405
Basic UDI-DI
0810101280130JG
Direct marketing DI
00810101280405
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
Netherlands
GUDID distribution status
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
US-MF-000040265
Authorised representative
CEpartner4U NL-AR-000000111

Similar devices in this category

Other devices filed under PAEDIATRIC PHOTOTHERAPY EQUIPMENT.

Other devices from Little Sparrows Technologies, Inc.

See all devices from Little Sparrows Technologies, Inc. →

Properties

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