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Activated Partial Thromboplastin Time (APTT) Test kit (Coagulation)

by Biobase Biodustry(Shandong) Co., Ltd. EUDAMED

Active European Union

Ref Reagent:2mL×10,CaCl2:25mL×1（501004）

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06936895303718 Basic UDI-DIDate8 Jul 2026RegisteredStatusActive

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  • Withdrawn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
Actived Partial Thromboplastin Time(APTT)Assay kit(Coagulation)
Model / Reference
Reagent:2mL×10, CaCl2:25mL×1（501004）
Primary DI / UDI-DI
06936895303718
Basic UDI-DI
B-06936895303718
EMDN Code
W0103020102 Activated partial thromboplastin time
Device Class
Class IVD General
Market of Registration
Germany

Manufacturer details

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

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Properties

Show properties
  • Reagent
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No