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BiliCocoon™ Fixation System

by Neomedlight

Ref BCC301

BiliCocoon Fixation System (BCC301) is a blanket/pad infant phototherapy unit (EU MDR Class I; FDA Class II; FDA product code LBI, Unit, Neonatal Phototherapy) made by Neomedlight, registered in EUDAMED on 4 May 2026 (Basic UDI-DI 376001257BCC301PU), cleared under FDA 510(k) K163526 on 6 Oct 2017 and listed in FDA GUDID since 3 Nov 2017 (UDI-DI 03760012570218), active as of 23 Oct 2026.

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

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 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K163526

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number376001257BCC301PU Basic UDI-DI 03760012570218UDI-DIDate4 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03760012570218 UDI-DI Date3 Nov 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK163526 Date6 Oct 2017DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 376001257BCC301PU registered 4 May 2026 Active
  • FDA 510(k) K163526 decided 6 Oct 2017 Active
  • FDA GUDID UDI-DI 03760012570218 listed 3 Nov 2017 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K163526
  2. Listed FDA GUDID 03760012570218
  3. Registered EUDAMED 376001257BCC301PU

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  • Withdrawn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
Blanket/pad infant phototherapy unit
Model / Ref / Catalog
BCC301
Primary DI / UDI-DI
03760012570218, 03760012570096
Basic UDI-DI
376001257BCC301PU
510(k) Number
FDA product code
LBI
EMDN code
Z12080499 Neonatology instruments - other
GMDN term
Blanket/pad infant phototherapy unit
Device class
Class I 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 · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I 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
FR-MF-000004044

Similar devices in this category

Other devices filed under NEONATOLOGY INSTRUMENTS.

Other devices from Neomedlight

See all devices from Neomedlight →

Properties

  • Serial number
  • Manufacturing date
Other properties (23, all answered No)