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AmniSure ROM Test

by QIAGEN Sciences LLC 2 variants

Ref FMRT-1-25-ML-RT

Active European Union

CE IVDD

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-14053228022357 Basic UDI-DI 14053228022357UDI-DIDate12 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  • Withdrawn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/IVDD Active

Specification

EUDAMED

Device Name
AmniSure ROM Test (25)
Model / Reference
FMRT-1-25-ML-RT
Primary DI / UDI-DI
14053228022357
Basic UDI-DI
B-14053228022357
EMDN Code
W0102019099 Specific proteins - other
Device Class
Class IVD General
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
US-MF-000014502
Authorised representative
QIAGEN GmbH DE-AR-000004971

Other devices from QIAGEN Sciences LLC

See all devices from QIAGEN Sciences LLC →

Properties

  • Animal Tissues
  • Reagent
  • Near-Patient Testing
  • Professional Testing

Other properties (6)

  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No