Skip to content

Coagulation Comprehensive Control

by Shenzhen Dymind Biotechnology Co., Ltd. China EUDAMED

Ref NX-0085-01Model CTRL-COM Coag Specification 1：1 × 0.5 mL (low-level)

EMDN W0103020799

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06941377307931 Basic UDI-DIDate3 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
CTRL-COM Coag Specification 1：1 × 0.5 mL (low-level), NX-0085-01
Primary DI / UDI-DI
06941377307931
Basic UDI-DI
B-06941377307931
EMDN Code
W0103020799 Haemostasis controls - other
Device Class
Class IVD General
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000024842
Authorised representative
Eunitor GmbH DE-AR-000005081

Other devices from Shenzhen Dymind Biotechnology Co., Ltd.

See all devices from Shenzhen Dymind Biotechnology Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Human Tissues
  • Animal Tissues
  • Reagent
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 06941377307931|B-06941377307931 61 fields · synced 24 Oct 2026