Skip to content

Anti-beta2GP1 ELISA (IgM)

by EUROIMMUN Medizinische Labordiagnostika AG

Ref EA 1632-9601-2 MModel EA 1632-2 M

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 linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number4049016EA16322MU5 Basic UDI-DI 04049016163961UDI-DIDate12 Oct 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Specification

EUDAMED

Model / Reference
EA 1632-2 M, EA 1632-9601-2 M
Primary DI / UDI-DI
04049016163961
Basic UDI-DI
4049016EA16322MU5
EMDN Code
W0102100503 Anti-b2-glycoprotein i antibodies
Device Class
Class B
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000005296

Other devices from EUROIMMUN Medizinische Labordiagnostika AG

See all devices from EUROIMMUN Medizinische Labordiagnostika AG →

Properties

  • Human Tissues
  • Animal Tissues
  • Professional Testing

Other properties (8)

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