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TestiQ

by Bio-Novum Sp. z o.o. EUDAMED

Active European Union

Ref BNA-100Model TestiQ

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number5905351316BNA100UY Basic UDI-DIDate20 Jan 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Device Name
Rapid Test Analyzer
Model / Reference
TestiQ, BNA-100
Primary DI / UDI-DI
05905351316679
Basic UDI-DI
5905351316BNA100UY
Direct Marketing DI
05905351316679
EMDN Code
W0201020201 Immunochemistry readers
Device Class
Class A
Market of Registration
Poland

Manufacturer details

EUDAMED SRN
PL-MF-000048483

Other devices from Bio-Novum Sp. z o.o.

See all devices from Bio-Novum Sp. z o.o. →

Properties

  • Professional Testing
  • Surgical Instrument

Other properties (9)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • New Device: No