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BILI-THERAPY Pad Type 60370

by Atom Medical Corp

Ref 60370

BILI-THERAPY Pad Type 60370 is a device classified as Class IIa in the EU and Class II in the US made by Atom Medical Corp, registered in EUDAMED on 28 Sep 2026 (Basic UDI-DI B-04942962603706) and listed in FDA GUDID since 21 Sep 2016 (UDI-DI 04942962603706), active as of 24 Oct 2026.

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

CE MDD

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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04942962603706 Basic UDI-DI 04942962603706UDI-DIDate28 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04942962603706 UDI-DI Date21 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-04942962603706 registered 28 Sep 2026 Active
  • FDA GUDID UDI-DI 04942962603706 listed 21 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04942962603706
  2. Registered EUDAMED B-04942962603706

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
BILI-THERAPY Pad Type
Generic name
Blanket/pad infant phototherapy unit
Model / Ref / Catalog
60370
Primary DI / UDI-DI
04942962603706
Basic UDI-DI
B-04942962603706
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
EU registration type
Legacy device (under a directive)
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution
Size
Depth — 220 Millimeter
Width — 150 Millimeter

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.

Related devices

Category: Blanket/pad infant phototherapy unit

Similar devices in this category

Other devices filed under PAEDIATRIC PHOTOTHERAPY EQUIPMENT.

Other devices from Atom Medical Corp

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Properties

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