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Anti-Tg Calibrators

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

Ref 105-005915-00, 105-051737-00Model 105-005664-00、105-005681-00、105-005915-00, 105-048322-00,105-048323-00,105-053343-00, 105-053344-00,105-051736-00,105-051737-00 EMDN W0102152210

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69449040004L-Anti-Tg***4M Basic UDI-DIDate16 Aug 2023RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Antibody to thyroglobulin(CLIA)、Anti-Tg Calibrators
Antibody to thyroglobulin (CLIA), Anti-Tg Calibrators
Model / Reference
105-005664-00、105-005681-00、105-005915-00, 105-005915-00, 105-048322-00, 105-048323-00, 105-053343-00, 105-053344-00, 105-051736-00, 105-051737-00
Primary DI / UDI-DI
06944904065502, 06903053100427
Basic UDI-DI
69449040004L-Anti-Tg***4M, 69449040AB740007767
EMDN Code
W0102152210, W0102152211
Device Class
Class B
Market of Registration
Germany

Manufacturer details

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

Other devices from Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

See all devices from Shenzhen Mindray Bio-Medical Electronics Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Human Tissues YesEUDAMEDNoEUDAMED
  • Animal Tissues YesEUDAMEDNoEUDAMED
  • Reagent
  • Professional Testing
  • New Device NoEUDAMEDYesEUDAMED
Other properties (6)
  • Sterile: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (2)

  • EUDAMED 3169d2d0-e76b-4527-9ca5-e8bbaa6c743d 61 fields · synced 24 Oct 2026
  • EUDAMED 06903053100427|69449040AB740007767 61 fields · synced 17 Jul 2026