Skip to content

Tissue Plasminogen Activator Inhibitor 1 Complex Kit（CLIA）

by Jiangxi Medicalsystem Biological Technology Co., Ltd. 2 variants

Ref CA1411BModel 100T

Active European Union

CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06978945081658 Basic UDI-DI 06978945081658UDI-DIDate24 May 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDD Active

Specification

EUDAMED

Model / Reference
100T, CA1411B
Primary DI / UDI-DI
06978945081658
Basic UDI-DI
B-06978945081658
EMDN Code
W0103020599 Fibrinolysis tests - other
Device Class
Class IVD General
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000050651
Authorised representative
Medunion S.L. ES-AR-000019366

Other devices from Jiangxi Medicalsystem Biological Technology Co., Ltd.

See all devices from Jiangxi Medicalsystem Biological Technology Co., Ltd. →

Properties

  • 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