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Thrombomodulin Chemiluminescence Immunoassay Kit

by Nanjing RealMind Biotech Co., Ltd. China EUDAMED

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

EMDN W0103020699

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06972719604975 Basic UDI-DIDate24 May 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Thrombomodulin Chemiluminescence Immunoassay Kit
Model / Reference
Reagents (include Calibrator 2x1mL/bottle and Control 2x1mL/bottle) 50tests/kit, 50tests/kit, Reagents (include Calibrator 1x1mL/bottle and Control 1x1mL/bottle) 50tests/kit, Reagents (include Calibrator 1x1mL/bottle and Control 2x1mL/bottle) 50tests/kit, Reagents (include Calibrator 1x1mL/bottle and Control 2x1mL/bottle) 100tests/kit, 100tests/kit
Primary DI / UDI-DI
06972719604975, 06972719603145, 06972719603152, 06972719603138
Basic UDI-DI
B-06972719604975, B-06972719603145, B-06972719603152, B-06972719603138
EMDN Code
W0103020699 Coagulation inhibitors - other
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 (4)

  • EUDAMED 16b7da66-6088-4964-a261-b5547859145e 61 fields · synced 22 Oct 2026
  • EUDAMED 06972719603145|B-06972719603145 61 fields · synced 18 May 2026
  • EUDAMED 06972719603152|B-06972719603152 61 fields · synced 19 May 2026
  • EUDAMED 06972719603138|B-06972719603138 61 fields · synced 19 May 2026