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Hemoglobin A1c Test Kit(Boronate Fluorescence Quenching Technology)

by Labnovation Technologies, Inc. China EUDAMED

Ref L-100104Model 100 Tests/Box

EMDN W01010699

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06938384631128 Basic UDI-DIDate20 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
100 Tests/Box, L-100104
Primary DI / UDI-DI
06938384631128
Basic UDI-DI
B-06938384631128
EMDN Code
W01010699 Clin. chem. rt & poc - other
Device Class
Class IVD General
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000015953
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

Other devices from Labnovation Technologies, Inc.

See all devices from Labnovation Technologies, Inc. →

Properties & raw data

Show properties, registry sources and raw records
  • Reagent
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 1c50da8d-298c-4d47-9bf7-e2df968935a3 61 fields · synced 22 Oct 2026