Skip to content

Automated Coagulation Analyzer

by Medcaptain Medical Technology Co., Ltd. United States EUDAMED

Ref Haema NXModel Haema N7/Haema N7p/Haema N9/Haema N9p/Haema NX/Haema NXp

EMDN W0202020102

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69268026HaemaN900000001X2 Basic UDI-DIDate28 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Device Name
Automated Coagulation Analyzer
Model / Reference
Haema N7/Haema N7p/Haema N9/Haema N9p/Haema NX/Haema NXp, Haema NX
Primary DI / UDI-DI
06926802610213
Basic UDI-DI
69268026HaemaN900000001X2
EMDN Code
W0202020102 Automated coagulometers
Device Class
Class A
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
CN-MF-000005925
Authorised representative
R Sight B.V. NL-AR-000010445

Other devices from Medcaptain Medical Technology Co., Ltd.

See all devices from Medcaptain Medical Technology Co., Ltd. →

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 06926802610213|69268026HAEMAN900000001X2 61 fields · synced 25 Oct 2026