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Accessory set

by Regen Lab SA

Ref BCA-SET3

Accessory set (BCA-SET3) is a Class IIa device made by Regen Lab SA, registered in EUDAMED on 7 Oct 2025 (Basic UDI-DI 764013898BCASETCB) and listed in FDA GUDID since 13 Oct 2020 (UDI-DI 07640138980329), 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 Number764013898BCASETCB Basic UDI-DI 07640138980329UDI-DIDate7 Oct 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number07640138980329 UDI-DI Date13 Oct 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 764013898BCASETCB registered 7 Oct 2025 Active
  • FDA GUDID UDI-DI 07640138980329 listed 13 Oct 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07640138980329
  2. Registered EUDAMED 764013898BCASETCB

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  • Withdrawn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
Venous butterfly needle/set
Model / reference
BCA-SET3
Primary DI / UDI-DI
07640138980329
Basic UDI-DI
764013898BCASETCB
EMDN code
A01010501 Needles for collection under vacuum, with safety systems
GMDN term
Venous butterfly needle/set
Device class
Class IIa
System or procedure pack
Procedure pack
EU registration type
System or procedure pack
Medical purpose
Accessory set for blood collection to be used with RegenKit®
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Supplied sterileEUDAMED
No
GUDID
Yes

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Supplied sterile UDI-DI 07640138980329: EUDAMED states No, FDA GUDID states Yes.

Manufacturer details

EUDAMED SRN
CH-PR-000049402

Similar devices in this category

Other devices filed under NEEDLES FOR COLLECTION UNDER VACUUM, WITH SAFETY SYSTEMS.

Other devices from Regen Lab SA

See all devices from Regen Lab SA →

Properties

  • Supplied sterile NoEUDAMEDYesGUDID
  • Single use
  • Prescription use
  • Convenience kit
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (8, all answered No)