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Architect

by Abbott Ireland, Diagnostics Division 47 variants

Ref 07K6740

Architect (07K6740) is a device classified as IVD General made by Abbott Ireland Diagnostics Division, registered in EUDAMED on 29 Oct 2026 (Basic UDI-DI B-00380740014537), 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-00380740014537 Basic UDI-DI 00380740014537UDI-DIDate29 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  • Withdrawn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

Device name
Afp
Model / reference
07K6740
Primary DI / UDI-DI
00380740014537
Basic UDI-DI
B-00380740014537
EMDN code
W0102039001 Alphafetoprotein
Device class
Class IVD General
EU registration type
Legacy device (under a directive)
EU market of registration
Ireland

Manufacturer details

EUDAMED SRN
IE-MF-000009849

Similar devices in this category

Other devices filed under ALPHAFETOPROTEIN.

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Properties

  • Contains human tissues or cells
  • Contains animal tissues or cells
  • Reagent
  • IVD kit
  • Professional testing
Other properties (8, all answered No)