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Amnioquick

by Biosynex France EUDAMED

Ref 1090003Model AMNIOQUICK

EMDN W0102160199

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number353267F00051N7R Basic UDI-DIDate2 Oct 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
AMNIOQUICK, 1090003
Primary DI / UDI-DI
03700531705135
Basic UDI-DI
353267F00051N7R
EMDN Code
W0102160199 Specific proteins rt & poc - other
Device Class
Class C
Market of Registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000014073

Properties & raw data

Show properties, registry sources and raw records
  • Human Tissues
  • Animal Tissues
  • Microbial Substances
  • Reagent
  • Near-Patient Testing
  • Professional Testing
Other properties (5)
  • Sterile: No
  • Self Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 91fb92b5-b423-49f2-aae2-a926785cac48 61 fields · synced 24 Oct 2026