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INSTI HCV Antibody Test Single

by bioLytical Laboratories Inc. Canada EUDAMED

Ref 90-1062-012 EMDN W0105020303

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-00686597201817 Basic UDI-DIDate30 Mar 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
INSTI HCV Ab Test CE es 300
Model / Reference
90-1062-012
Primary DI / UDI-DI
00686597201817
Basic UDI-DI
B-00686597201817
EMDN Code
W0105020303 Hcv antibody (total)
Device Class
Class IVD Annex II List A
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
CA-MF-000023304
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from Biolytical Laboratories Inc.

See all devices from Biolytical Laboratories Inc. →

Properties & raw data

Show properties, registry sources and raw records
  • Near-Patient Testing
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 00686597201817|B-00686597201817 61 fields · synced 24 Oct 2026