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RealTime

by Abbott Molecular Inc. 8 variants

Ref 2G34-80

RealTime (2G34-80) is a Class D device made by Abbott Molecular, registered in EUDAMED on 19 Aug 2026 (Basic UDI-DI 0884999RTG023489), active as of 7 Nov 2026.

Active European Union

CE IVDR

Valid until

15 Jul 2029

CE IVDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier BSI Group The Netherlands B.V.

Trust

Unverified

Source EUDAMED, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number0884999RTG023489 Basic UDI-DI 00884999001671UDI-DIDate19 Aug 2026RegisteredStatusActive

Official records

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • IVDR 798928 Active Amended

    Technical documentation EU IVDR

    Certifier
    BSI Group The Netherlands B.V. 2797
    Issued
    19 Mar 2025
    Expires
    15 Jul 2029
    Valid from
    7 Apr 2025
    Reason
    Other

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Specification

EUDAMED

Device name
Abbott Realtime Hbv
Model / reference
2G34-80
Primary DI / UDI-DI
00884999001671
Basic UDI-DI
0884999RTG023489
EMDN code
W0105020216 Hepatitis b virus - na reagents
Device class
Class D
EU registration type
Standard device
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
US-MF-000017776
Authorised representative
Abbott GmbH DE-AR-000009457

Similar devices in this category

Other devices filed under HEPATITIS B VIRUS - NA REAGENTS.

Other devices from Abbott Molecular

See all devices from Abbott Molecular →

Properties

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