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Architect

by Abbott Ireland Diagnostics Division 79 variants

Ref 07K6101

Architect (07K6101) is a Class B device made by Abbott Ireland Diagnostics Division, registered in EUDAMED on 26 Oct 2026 (Basic UDI-DI 038074ARK0761NA), active as of 7 Nov 2026.

Active European Union

CE IVDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number038074ARK0761NA Basic UDI-DI 00380740014124UDI-DIDate26 Oct 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Specification

EUDAMED

Device name
Architect B12
Model / reference
07K6101
Primary DI / UDI-DI
00380740014124
Basic UDI-DI
038074ARK0761NA
EMDN code
W0102152206 Anaemia related/vitamin standards and calibrators
Device class
Class B
EU registration type
Standard device
EU market of registration
Ireland

Manufacturer details

EUDAMED SRN
IE-MF-000010070

Similar devices in this category

Other devices filed under ANAEMIA RELATED/VITAMIN STANDARDS AND CALIBRATORS.

Other devices from Abbott Ireland Diagnostics Division

See all devices from Abbott Ireland Diagnostics Division →

Properties

  • Contains human tissues or cells
  • Contains animal tissues or cells
  • Contains substances of microbial origin
  • Reagent
  • IVD kit
  • Professional testing
Other properties (7, all answered No)