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BIOSYNEX AMPLIQUICK Fecal Pretreatment

by Biosynex

Ref 3150065Model BIOSYNEX AMPLIQUICK Fecal Pretreatment

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, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number353267F00168P8W Basic UDI-DI 03532678594675UDI-DIDate19 May 2022RegisteredStatusActive

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  • Withdrawn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/IVDR Active

Specification

EUDAMED

Model / Reference
BIOSYNEX AMPLIQUICK Fecal Pretreatment, 3150065
Primary DI / UDI-DI
03532678594675
Basic UDI-DI
353267F00168P8W
Unit of Use DI
03532670104087
EMDN Code
W05019001 Faeces collection devices
Device Class
Class A
EU market of registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000014073

Other devices from Biosynex

See all devices from Biosynex →

Properties

  • Reagent
  • Professional Testing

Other properties (9)

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