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Glycated Hemoglobin A1c Calibrator

by MedicalSystem Biotechnology Co., Ltd. FDA registration: China EUDAMED

Ref JZ411TYModel 5×1mL EMDN W0102152208

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06970291983426 Basic UDI-DIDate22 Sep 2022RegisteredStatusActive

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  • Withdrawn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 22 Oct 2026

Model / Reference
5×1mL, JZ411TY
Primary DI / UDI-DI
06970291983426
Basic UDI-DI
B-06970291983426
EMDN Code
W0102152208 Standards and calibrators for individual and specific hormones /proteins
Device Class
Class IVD General
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000010246
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Medicalsystem Biotechnology Co., Ltd.

See all devices from Medicalsystem Biotechnology Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Reagent
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 5bee3333-818f-4003-9f1e-80aa1a38391b 61 fields · synced 22 Oct 2026