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AmniSure ROM Test

by QIAGEN Sciences LLC 2 variants

Ref FMRT-1-25-IVDR

Active European Union

CE IVDR

Valid until

9 Nov 2030

CE IVDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier TÜV Rheinland LGA Products GmbH

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 7 Nov 2026. What this means

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number4053228RAS0000000000001MP Basic UDI-DI 14053228046391UDI-DIDate19 Oct 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Specification

EUDAMED

Device Name
AmniSure ROM (Rupture of [fetal] Membranes) Test
Model / Reference
FMRT-1-25-IVDR
Primary DI / UDI-DI
14053228046391
Basic UDI-DI
4053228RAS0000000000001MP
Direct Marketing DI
14053228046391
EMDN Code
W0102019099 Specific proteins - other
Device Class
Class C
EU market of registration
Germany

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 (7)

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