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INSTI HIV Self Test (no pipette variant, packaged in a box)

by bioLytical Laboratories Inc. Canada EUDAMED

Ref 90-1059 EMDN W0105030402

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-00686597010594 Basic UDI-DIDate25 May 2022RegisteredStatusActive

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  • Withdrawn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 HIV Self Test
Model / Reference
90-1059
Primary DI / UDI-DI
00686597010594
Basic UDI-DI
B-00686597010594
EMDN Code
W0105030402 HIV multiple antibody
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
  • Self Testing
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 44e8a5e0-ceaa-4725-bb4f-fc168e863b14 61 fields · synced 24 Oct 2026