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BIOSYNEX AMPLIQUICK Lysis

by Biosynex France EUDAMED

Ref 3150059_SEC01, 3150059_SEC02Model BIOSYNEX AMPLIQUICK Lysis EMDN W01010199

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number353267F00061P82 Basic UDI-DIDate9 May 2022RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
BIOSYNEX AMPLIQUICK Lysis, 3150059_SEC01, 3150059_SEC02
Primary DI / UDI-DI
03532678592077, 03532678593074
Basic UDI-DI
353267F00061P82
Unit of Use DI
03532670102847, 03532670103653
EMDN Code
W01010199 Enzymes - other
Device Class
Class A
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
  • 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

Sources (2)

  • EUDAMED 027315db-fbed-4c8a-bccf-389394feafcb 61 fields · synced 22 Oct 2026
  • EUDAMED 03532678593074|353267F00061P82 61 fields · synced 17 May 2026