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A-CP-Kit-2

by Regen Lab SA

Ref A-CP-2

A-CP-Kit-2 (A-CP-2) is a device classified as Class IIb in the EU and Class II in the US made by Regen Lab SA, registered in EUDAMED on 26 Jan 2023 (Basic UDI-DI B-07640138981166) and listed in FDA GUDID since 15 Sep 2016 (UDI-DI 07640138981166), active as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-07640138981166 Basic UDI-DI 07640138981166UDI-DIDate26 Jan 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number07640138981166 UDI-DI Date15 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-07640138981166 registered 26 Jan 2023 Active
  • FDA GUDID UDI-DI 07640138981166 listed 15 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07640138981166
  2. Registered EUDAMED B-07640138981166

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  • Withdrawn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

Generic name
Haematological concentrate system preparation kit, platelet concentration
Model / reference
A-CP-2
Primary DI / UDI-DI
07640138981166 EUDAMED
07640138980503 GUDID
Basic UDI-DI
B-07640138981166
FDA product code
ORG
EMDN code
B0501, B0599
GMDN term
Haematological concentrate system preparation kit, platelet concentration
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
864.9245
EU registration type
Legacy device (under a directive)
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
07640138981166
GUDID
07640138980503
Device classEUDAMED
Class IIb
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists 07640138981166; FDA GUDID lists 07640138980503), so their flags are not compared. Device class is stated on each registry's own scale: Class IIb 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
CH-MF-000032231
Authorised representative
RegenLab France FR-AR-000011953

Similar devices in this category

Other devices filed under PLATELET GEL AUTOMATIC PREPARATION DEVICES (EXCLUDING BAGS).

Other devices from Regen Lab SA

See all devices from Regen Lab SA →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (17, all answered No)