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Bilisoft 2.0 009766

by Lumitex, Inc.

Ref 2103122-001Model BiliSoft 2.0 PT Systems, Large Pad, English, US Plug

Bilisoft 2.0 009766 is a blanket/pad infant phototherapy unit (EU MDD Class IIa; FDA Class II; FDA product code LBI, Unit, Neonatal Phototherapy) made by Lumitex, Inc., registered in EUDAMED on 2 Mar 2026 (Basic UDI-DI B-00812432020460), cleared under FDA 510(k) K053568 on 17 Apr 2006 and listed in FDA GUDID since 15 Nov 2018 (UDI-DI 00812432020460), active as of 22 Oct 2026.

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

CE MDD 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) K053568

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/MDD EUDAMED NumberB-00812432020460 Basic UDI-DI 00812432020460UDI-DIDate2 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00812432020460 UDI-DI Date15 Nov 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK053568 Date17 Apr 2006DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00812432020460 registered 2 Mar 2026 Active
  • FDA 510(k) K053568 decided 17 Apr 2006 Active
  • FDA GUDID UDI-DI 00812432020460 listed 15 Nov 2018 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K053568
  2. Listed FDA GUDID 00812432020460
  3. Registered EUDAMED B-00812432020460

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Bilisoft 2.0
Generic name
Blanket/pad infant phototherapy unit
Model / reference
BiliSoft 2.0 PT Systems EUDAMED
Large Pad EUDAMED
English EUDAMED
US Plug EUDAMED
2103122-001 EUDAMED
009766 GUDID
Primary DI / UDI-DI
00812432020460
Basic UDI-DI
B-00812432020460
510(k) Number
FDA product code
LBI
EMDN code
Z12080401 Paediatric phototherapy equipment
GMDN term
Blanket/pad 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
Legacy device (under a directive)
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
BiliSoft 2.0 PT Systems, Large Pad, English, US Plug
2103122-001
GUDID
009766
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: Blanket/pad infant phototherapy unit

Cleared under the same submission (K053568)

and 2 more cleared under K053568

Similar devices in this category

Other devices filed under PAEDIATRIC PHOTOTHERAPY EQUIPMENT.

Other devices from Lumitex, Inc.

See all devices from Lumitex, Inc. →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (20, all answered No)