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Amnioquick Duo+

by Biosynex France EUDAMED

Ref 1090004_CModel AMNIOQUICK DUO+ EMDN W0102160199

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberB-03532670103714 Basic UDI-DIDate17 Jul 2026RegisteredStatusActive
European UnionCE/IVDD NumberB-03532670103714 Basic UDI-DIDate17 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDR, CE/IVDD Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Model / Reference
1090004_C, AMNIOQUICK DUO+
Primary DI / UDI-DI
03532670103714
Basic UDI-DI
B-03532670103714, 353267F00077P8R
EMDN Code
W0102160199 Specific proteins rt & poc - other
Device Class
Class IVD General
Class B
Market of Registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000014073

Other devices from Biosynex

See all devices from Biosynex →

Properties & raw data

Show properties, registry sources and raw records
  • Human Tissues
  • Animal Tissues
  • Microbial Substances
  • Reagent
  • Professional Testing
Other properties (6)
  • Sterile: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (2)

  • EUDAMED fb427ca8-8401-4cdc-a85f-3aea5cceb4db 61 fields · synced 22 Oct 2026
  • EUDAMED 03532670103714|353267F00077P8R 61 fields · synced 25 Oct 2026