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Activated Partial Thromboplastin Time (APTT) Reagent(Ellagic Acid)

by SysCan BioTech (Suzhou) Co., Ltd. EUDAMED

Active European Union

Ref Ci-APTT-04EModel Coagulation Analyzer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06974490250419 Basic UDI-DIDate9 Aug 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDD Expiring

Certificates

0 certificates · EUDAMED

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

Specification

EUDAMED

Model / Reference
Coagulation Analyzer, Ci-APTT-04E
Primary DI / UDI-DI
06974490250419
Basic UDI-DI
B-06974490250419
EMDN Code
W0103020102 Activated partial thromboplastin time
Device Class
Class IVD General
Market of Registration
Romania

Manufacturer details

EUDAMED SRN
CN-MF-000040462
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from SysCan BioTech (Suzhou) Co., Ltd

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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