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Total Thyroxine Chemiluminescence Immunoassay Kit

by Nanjing RealMind Biotech Co., Ltd. China EUDAMED

Ref 100tests/kit, 50tests/kitModel Reagents（include Calibrator 2x1mL/bottle and Control 2x1mL/bottle )100tests/kit, Reagents（include Calibrator 2x1mL/bottle and Control 2x1mL/bottle )50tests/kit, Reagents（include Calibrator 1x1mL/bottle and Control 2x1mL/bottle )100tests/kit, Reagents（include Calibrator 1x1mL/bottle and Control 2x1mL/bottle )50tests/kit, Reagents（include Calibrator 1x1mL/bottle and Control 1x1mL/bottle )50tests/kit EMDN W01020407

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06972719604241 Basic UDI-DIDate22 May 2025RegisteredStatusActive

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  • Withdrawn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

Device Name
Total Thyroxine Chemiluminescence Immunoassay Kit
Model / Reference
Reagents（include Calibrator 2x1mL/bottle and Control 2x1mL/bottle )100tests/kit, 100tests/kit, Reagents（include Calibrator 2x1mL/bottle and Control 2x1mL/bottle )50tests/kit, 50tests/kit, Reagents（include Calibrator 1x1mL/bottle and Control 2x1mL/bottle )100tests/kit, Reagents（include Calibrator 1x1mL/bottle and Control 2x1mL/bottle )50tests/kit, Reagents（include Calibrator 1x1mL/bottle and Control 1x1mL/bottle )50tests/kit
Primary DI / UDI-DI
06972719604241, 06972719604258, 06972719602032, 06972719602056, 06972719602049
Basic UDI-DI
B-06972719604241, B-06972719604258, B-06972719602032, B-06972719602056, B-06972719602049
EMDN Code
W01020407 Thyroxine
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 (5)

  • EUDAMED be8df99d-42f2-4800-a1c5-a87257309f5a 61 fields · synced 22 Oct 2026
  • EUDAMED 06972719604258|B-06972719604258 61 fields · synced 17 May 2026
  • EUDAMED 06972719602032|B-06972719602032 61 fields · synced 17 May 2026
  • EUDAMED 06972719602056|B-06972719602056 61 fields · synced 19 May 2026
  • EUDAMED 06972719602049|B-06972719602049 61 fields · synced 19 May 2026