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Bc+™ 2U026S

by Copan Italia SpA

Ref 2U026S

Bc+ 2U026S is an evacuated blood collection tube IVD (EU IVDR Class A; FDA Class I; FDA product code KDT, Container, Specimen Mailer And Storage, Sterile) made by Copan Italia SpA, registered in EUDAMED on 20 May 2026 (Basic UDI-DI 80533260DD0190AM001C5) and listed in FDA GUDID since 7 Dec 2022 (UDI-DI 08053326004537), active as of 23 Oct 2026.

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

CE IVDR

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
European UnionCE/IVDR EUDAMED Number80533260DD0190AM001C5 Basic UDI-DI 08053326004537UDI-DIDate20 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08053326004537 UDI-DI Date7 Dec 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 80533260DD0190AM001C5 registered 20 May 2026 Active
  • FDA GUDID UDI-DI 08053326004537 listed 7 Dec 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08053326004537
  2. Registered EUDAMED 80533260DD0190AM001C5

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Bc+ EUDAMED
Bc+™ GUDID
Generic name
Evacuated blood collection tube IVD, no additive
Model / Ref / Catalog
2U026S
Primary DI / UDI-DI
08053326004537 EUDAMED
18053326004534 GUDID
Basic UDI-DI
80533260DD0190AM001C5
FDA product code
KDT
EMDN code
W050301020102 Samples analyses, plastic tubes without additives
GMDN term
Evacuated blood collection tube IVD, no additive
Device class
Class A EUDAMED
Class I GUDID
Regulation number
864.3250
EU registration type
Standard device
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
08053326004537
GUDID
18053326004534
Device classEUDAMED
Class A
GUDID
Class I

The registries describe this device under different primary UDI-DIs (EUDAMED lists 08053326004537; FDA GUDID lists 18053326004534), so their flags are not compared. Device class is stated on each registry's own scale: Class A in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Evacuated blood collection tube IVD, no additive

Similar devices in this category

Other devices filed under SAMPLES ANALYSES, PLASTIC TUBES.

Other devices from Copan Italia SpA

See all devices from Copan Italia SpA →

Properties

  • Supplied sterile
  • Single use
  • Professional testing
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)