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Tissue Plasminogen Activator/ Plasminogen Activator Inhibitor-1 Complex Chemiluminescence Immunoassay Kit

by Nanjing RealMind Biotech Co., Ltd. EUDAMED

Active European Union

Ref 50tests/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

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06972719604999 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  • Withdrawn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

Device Name
Tissue Plasminogen Activator/ Plasminogen Activator Inhibitor-1 Complex 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
Primary DI / UDI-DI
06972719604999, 06972719603176, 06972719603183
Market of Registration
Hungary

Manufacturer details

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

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