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Micro-Albumin Qualitative Rapid Test

by Hangzhou Fanttest Biotech Co., Ltd. EUDAMED

Active European Union

Ref OMA-102Model 25 test/kit

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06980497432307 Basic UDI-DIDate14 Oct 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Expiring

Certificates

0 certificates · EUDAMED

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

Specification

EUDAMED

Device Name
Micro-Albumin Qualitative Rapid Test
Model / Reference
25 test/kit, OMA-102
Primary DI / UDI-DI
06980497432307
Basic UDI-DI
B-06980497432307
EMDN Code
W0102160101 Albumin incl. ualbumin rt & poc
Device Class
Class IVD General
Market of Registration
Cyprus

Manufacturer details

EUDAMED SRN
CN-MF-000026134
Authorised representative
RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202

Other devices from Hangzhou Fanttest Biotech Co., Ltd.

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Properties

  • Professional Testing

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
  • Surgical Instrument: No