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HbA1c Calibrator Kit

by Labnovation Technologies, Inc. China EUDAMED

Ref L-500301Model Level 1: 0.1 mL×3; Level 2: 0.1 mL×3 EMDN W0101050399

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06938384631029 Basic UDI-DIDate21 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  • Withdrawn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 · synced 25 Oct 2026

Model / Reference
Level 1: 0.1 mL×3, Level 2: 0.1 mL×3, L-500301
Primary DI / UDI-DI
06938384631029
Basic UDI-DI
B-06938384631029
EMDN Code
W0101050399 Calibrators and standards (clinical chemistry) - 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.

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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 df51897a-71c4-472b-b0f4-358504c292b8 61 fields · synced 25 Oct 2026