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Thrombin-Antithrombin III Complex Chemiluminescence Immunoassay Kit

by Nanjing RealMind Biotech Co., Ltd. China EUDAMED

Ref 100tests/kitModel Reagents (include Calibrator 2x1mL/bottle and Control 2x1mL/bottle) 100tests/kit, Reagents (include Calibrator 1x1mL/bottle and Control 2x1mL/bottle) 100tests/kit EMDN W0103020307

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06972719604944 Basic UDI-DIDate24 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  • Withdrawn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
Thrombin-Antithrombin III Complex Chemiluminescence Immunoassay Kit
Model / Reference
Reagents (include Calibrator 2x1mL/bottle and Control 2x1mL/bottle) 100tests/kit, 100tests/kit, Reagents (include Calibrator 1x1mL/bottle and Control 2x1mL/bottle) 100tests/kit
Primary DI / UDI-DI
06972719604944, 06972719603077
Basic UDI-DI
B-06972719604944, B-06972719603077
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.

See all devices from Nanjing RealMind Biotech Co., Ltd. →

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 (2)

  • EUDAMED 8a61eda3-2734-4c23-952c-aa9bbbceaa7b 61 fields · synced 22 Oct 2026
  • EUDAMED 06972719603077|B-06972719603077 61 fields · synced 19 May 2026