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Semi-auto Coagulation Analyzer

by Beijing ZONCI Technology Development Co., Ltd EUDAMED

Active European Union

Ref XL40

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number6971288645E6 Basic UDI-DIDate7 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates

0 certificates · EUDAMED

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

Specification

EUDAMED

Device Name
Semi-auto Coagulation Analyzer
Model / Reference
XL40
Primary DI / UDI-DI
06971288640001
Basic UDI-DI
6971288645E6
Direct Marketing DI
06971288640001
EMDN Code
W0202020101 Semi-automated coagulometers
Device Class
Class A
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
CN-MF-000048322
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

Other devices from Beijing ZONCI Technology Development Co., Ltd

Properties

  • Professional Testing
  • New Device

Other properties (9)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No