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Albumin (Alb)

by Randox Laboratories Limited

Ref AB8000

Albumin (Alb) (AB8000) is a device classified as IVD General made by Randox Laboratories Limited, registered in EUDAMED on 27 Oct 2026 (Basic UDI-DI B-05055273208108), active as of 7 Nov 2026.

Active European Union

CE IVDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-05055273208108 Basic UDI-DI 05055273208108UDI-DIDate27 Oct 2026RegisteredStatusActive

Official records

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDD Active

Specification

EUDAMED

Model / reference
AB8000
Primary DI / UDI-DI
05055273208108
Basic UDI-DI
B-05055273208108
EMDN code
W01010201 Albumin (cc)
Device class
Class IVD General
EU registration type
Legacy device (under a directive)
EU market of registration
Northern Ireland

Manufacturer details

EUDAMED SRN
XI-MF-000028410

Similar devices in this category

Other devices filed under ALBUMIN (CC).

Other devices from Randox Laboratories Limited

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Properties

  • Reagent
  • IVD kit
  • Professional testing
Other properties (9, all answered No)