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m2000

by Abbott Molecular Inc. 18 variants

Ref 05N92-001

Active European Union

CE IVDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number0884999RTN0106AC Basic UDI-DI 00884999015463UDI-DIDate13 Oct 2026RegisteredStatusActive

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  • Withdrawn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/IVDR Active

Specification

EUDAMED

Device Name
M2000 Sample Input Process Accessories
Model / Reference
05N92-001
Primary DI / UDI-DI
00884999015463
Basic UDI-DI
0884999RTN0106AC
EMDN Code
W02079085 Various general purpose IVD instruments - consumables
Device Class
Class A
EU market of registration
Germany

Manufacturer details

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

Other devices from Abbott Molecular

See all devices from Abbott Molecular →

Properties

  • Professional Testing

Other properties (10)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No