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BiliCocoon™ Bag System

by Neomedlight

Ref BCC201, CM301

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 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.

Overview

Unlock the full potential of your patients with the BiliCocoon Bag System, a revolutionary medical device designed to simplify and streamline clinical workflows.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-03760012570126 Basic UDI-DI Date4 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03760012570126 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 B-03760012570126 registered 4 May 2026 Active
  • FDA 510(k) K163526 decided 6 Oct 2017 Active
  • FDA GUDID UDI-DI 03760012570126 listed 3 Nov 2017 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K163526
  2. Listed FDA GUDID 03760012570126
  3. Registered EUDAMED B-03760012570126

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  • Withdrawn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
BiliCocoon™ Bag System EUDAMEDGUDID
CareMin650 ™ Derma Pad EUDAMED
Generic name
Blanket/pad infant phototherapy unit
Model / Ref / Catalog
BCC201, CM301
Primary DI / UDI-DI
03760012570126, 03760012570058
Basic UDI-DI
B-03760012570126, 376001257CM301UR
510(k) Number
FDA product code
LBI
EMDN code
Z12080401, Z12040202
GMDN term
Blanket/pad infant phototherapy unit
Device class
Class IIa EUDAMED
Class I 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)
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 IIa
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa and Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes.

Manufacturer details

EUDAMED SRN
FR-MF-000004044

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Properties

  • Prescription use
  • Convenience kit YesGUDIDNoGUDID
  • Serial number
  • Manufacturing date
Other properties (21, all answered No)