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Fully Automated Coagulation Analyzer

by Zybio Inc. China EUDAMED

Ref 1301404Model EXT 3800, EXT 3810, EXT 3820

EMDN W0202020102

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69732628600109ZV Basic UDI-DIDate14 Oct 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Fully Automated Coagulation Analyzer
Model / Reference
EXT 3800, EXT 3810, EXT 3820, 1301404
Primary DI / UDI-DI
06941967224389
Basic UDI-DI
69732628600109ZV
EMDN Code
W0202020102 Automated coagulometers
Device Class
Class A
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
CN-MF-000003349
Authorised representative
QbD RepS BV BE-AR-000000040

Other devices from Zybio Inc.

See all devices from Zybio Inc. →

Properties & raw data

Show properties, registry sources and raw records
  • Professional Testing
  • Surgical Instrument
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
  • New Device: No

Sources (1)

  • EUDAMED 06941967224389|69732628600109ZV 61 fields · synced 24 Oct 2026