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Insti HIV Antibody Self-Test

by bioLytical Laboratories Inc. 3 variants

Ref 90-1126-001 and 90-1126-002

Active European Union

CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-00686597201244 Basic UDI-DI 00686597201244UDI-DIDate30 Mar 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDD Active

Specification

EUDAMED

Device Name
INSTI HIV Self Test CE elenru 10 and INSTI HIV Self Test CE elenru 250
Model / Reference
90-1126-001 and 90-1126-002
Primary DI / UDI-DI
00686597201244
Basic UDI-DI
B-00686597201244
EMDN Code
W0105030402 HIV multiple antibody
Device Class
Class IVD Annex II List A
EU 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

  • 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