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Thrombin-Antithrombin III Complex Chemiluminescence Immunoassay Kit

by Nanjing RealMind Biotech Co., Ltd. China EUDAMED

Ref 215420001Model Reagents (include Calibrator 1x1mL/bottle and Control 1x1mL/bottle): 100tests/kit EMDN W0103020307

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06972719601011 Basic UDI-DIDate10 Oct 2022RegisteredStatusActive

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  • Withdrawn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
Thrombin-Antithrombin III Complex Chemiluminescence Immunoassay Kit
Model / Reference
Reagents (include Calibrator 1x1mL/bottle and Control 1x1mL/bottle): 100tests/kit, 215420001
Primary DI / UDI-DI
06972719601011
Basic UDI-DI
B-06972719601011
EMDN Code
W0103020307 Thrombin-antithrombin iii-complex
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

Other devices from Nanjing RealMind Biotech Co., Ltd.

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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 (1)

  • EUDAMED 35a8df7a-ddb8-4cc7-b283-bcb61ddd49f5 61 fields · synced 24 Oct 2026