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Accessory Set BCA-SET3-U

by Regen Lab SA

Accessory Set BCA-SET3-U is a device made by Regen Lab SA, registered in EUDAMED and listed in FDA GUDID since 5 Oct 2020 (UDI-DI 07640138981432), active as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number07640138981432 UDI-DI Date5 Oct 2020ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Active
  • FDA GUDID UDI-DI 07640138981432 listed 5 Oct 2020 Listed

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  • Withdrawn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

Trade name
Accessory Set
Generic name
Venous butterfly needle/set
Model / reference
BCA-SET3-U
Primary DI / UDI-DI
07640138981432
GMDN term
Venous butterfly needle/set
GUDID distribution status
In Commercial Distribution

Related devices

Category: Venous butterfly needle/set

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 (8, all answered No)