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Prothrombin Time (PT) Test Kit (Coagulation)

by Biobase Biodustry(Shandong) Co., Ltd. 7 variants

Ref Freeze-dried：Reagent:2mL×10,Reconstitution solution:25mL×1（501003）Model Freeze-dried：Reagent:2mL×10,Reconstitution solution:25mL×1（502003）

Active European Union

CE IVDD

Valid until

No date given

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06936895303640 Basic UDI-DI 06936895303640UDI-DIDate8 Jul 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  • Withdrawn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

Device name
Prothrombin Time (PT) Assay Kit(Coagulation)
Model / reference
Freeze-dried：Reagent:2mL×10, Reconstitution solution:25mL×1（502003）, Reconstitution solution:25mL×1（501003）
Primary DI / UDI-DI
06936895303640
Basic UDI-DI
B-06936895303640
EMDN code
W0103020101 Prothrombin time ( quick test )
Device class
Class IVD General
EU registration type
Legacy device (under a directive)
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000025015
Authorised representative
Luxus Lebenswelt GmbH DE-AR-000005110

Other devices from Biobase Biodustry(Shandong) Co., Ltd.

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Properties

  • Reagent
  • IVD kit
  • Professional testing

Other properties (9)

  • Supplied sterile: No
  • Sterilise before use: No
  • Contains human tissues or cells: No
  • Contains animal tissues or cells: No
  • Contains substances of microbial origin: No
  • Self-testing: No
  • Near-patient testing: No
  • Companion diagnostics: No
  • IVD instrument: No