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ReLIA

by ReLIA Biotechnologies (Jiangsu), Inc. EUDAMED

Active European Union

Ref RF16358-20T

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06971354101481 Basic UDI-DIDate19 May 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  • Withdrawn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
Glycosylated Hemoglobin (HbA1c) Assay Kit (Fluorescence Immunoassay)
Model / Reference
RF16358-20T
Primary DI / UDI-DI
06971354101481
Basic UDI-DI
B-06971354101481
EMDN Code
W0101060107 Hba1c test strips
Device Class
Class IVD General
Market of Registration
Slovenia

Manufacturer details

EUDAMED SRN
CN-MF-000042042
Authorised representative
RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202

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See all devices from ReLIA Biotechnologies (Jiangsu), Inc. →

Properties

  • Animal Tissues
  • Reagent
  • Professional Testing

Other properties (7)

  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No