Skip to content

RegenET

by Regen Lab SA 3 variants

Ref R-ET-3

RegenET (R-ET-3) is a device classified as Class IIa in the EU and Class I in the US made by Regen Lab SA, registered in EUDAMED on 7 Oct 2025 (Basic UDI-DI 764013898REGENETCTT2) and listed in FDA GUDID since 24 Feb 2020 (UDI-DI 07640138981364), active as of 22 Oct 2026.

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

CE MDR

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/MDR EUDAMED Number764013898REGENETCTT2 Basic UDI-DI 07640138981364UDI-DIDate7 Oct 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number07640138981364 UDI-DI Date24 Feb 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 764013898REGENETCTT2 registered 7 Oct 2025 Active
  • FDA GUDID UDI-DI 07640138981364 listed 24 Feb 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07640138981364
  2. Registered EUDAMED 764013898REGENETCTT2

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Generic name
Haematological concentrate system preparation kit, platelet concentration
Device name
RegenET/CT
Model / reference
R-ET-3
Primary DI / UDI-DI
07640138981364
Basic UDI-DI
764013898REGENETCTT2, B-07640138981364
FDA product code
KJC
EMDN code
B019001, B06
GMDN term
Haematological concentrate system preparation kit, platelet concentration
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
864.2240
EU registration type
Standard device
Legacy device (under a directive)
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class I

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class I 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 BLOOD BAGS AND KITS - VARIOUS.

Other devices from Regen Lab SA

See all devices from Regen Lab SA →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Convenience kit
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (18, all answered No)