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Insti HIV Antibody Self-Test

by bioLytical Laboratories Inc. EUDAMED

Active European Union

Ref 90-1123-001

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-00686597200889 Basic UDI-DIDate13 Apr 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  • Withdrawn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

Device Name
INSTI HIV Self Test CE eelvlt 250
Model / Reference
90-1123-001
Primary DI / UDI-DI
00686597200889
Basic UDI-DI
B-00686597200889
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.

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Properties

Show properties
  • 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