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Thyroid Stimulating Antibody Chemiluminescence Immunoassay Kit

by Nanjing RealMind Biotech Co., Ltd. China EUDAMED

Ref 50tests/kitModel Reagents（include Calibrator 1x1mL/bottle and Control 2x1mL/bottle )50tests/kit, Reagents（include Calibrator 2x1mL/bottle and Control 2x1mL/bottle ) 50tests/kit, Reagents（include Calibrator 1x1mL/bottle and Control 1x1mL/bottle )50tests/kit EMDN W0102100302

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06972719607693 Basic UDI-DIDate23 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  • Withdrawn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 24 Oct 2026

Device Name
Thyroid Stimulating Antibody Chemiluminescence Immunoassay Kit
Model / Reference
Reagents（include Calibrator 1x1mL/bottle and Control 2x1mL/bottle )50tests/kit, 50tests/kit, Reagents（include Calibrator 2x1mL/bottle and Control 2x1mL/bottle ) 50tests/kit, Reagents（include Calibrator 1x1mL/bottle and Control 1x1mL/bottle )50tests/kit
Primary DI / UDI-DI
06972719607693, 06972719607709, 06972719607686
Basic UDI-DI
B-06972719607693, B-06972719607709, B-06972719607686
EMDN Code
W0102100302 Tsh receptor antibodies
Device Class
Class IVD General
Market of Registration
Hungary

Manufacturer details

EUDAMED SRN
CN-MF-000024838
Authorised representative
Lotus NL B.V. NL-AR-000000121

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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 (3)

  • EUDAMED 6d58b498-8116-4119-84a0-33142ba72b23 61 fields · synced 24 Oct 2026
  • EUDAMED 06972719607709|B-06972719607709 61 fields · synced 21 Jul 2026
  • EUDAMED 06972719607686|B-06972719607686 61 fields · synced 6 Oct 2026