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Calcitonin(CLIA)

by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. China EUDAMED

Ref 105-008685-00, 105-008690-00Model 105-008685-00、105-008690-00、105-008550-00

EMDN W0102060301

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69449040004L-CT********LY Basic UDI-DIDate21 Sep 2023RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Calcitonin(CLIA)、Calcitonin Calibrators
Model / Reference
105-008685-00、105-008690-00、105-008550-00, 105-008685-00, 105-008690-00
Primary DI / UDI-DI
06944904091372, 06944904091426
Basic UDI-DI
69449040004L-CT********LY
EMDN Code
W0102060301 Calcitonin
Device Class
Class C
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000014156
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Properties & raw data

Show properties, registry sources and raw records
  • Human Tissues
  • Animal Tissues
  • Reagent
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (2)

  • EUDAMED 026ed706-1046-49d4-a349-a01a1390087d 61 fields · synced 24 Oct 2026
  • EUDAMED 06944904091426|69449040004L-CT********LY 61 fields · synced 18 May 2026