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Fibrinogen (FIB) Assay Kit (Clotting Method)

by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. United States EUDAMED

Ref 105-023622-00, 105-023627-00Model 105-023622-00、105-023623-00、105-023624-00、105-023625-00、105-023626-00、105-023627-00

EMDN W0103020201

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69449040AB75000065V Basic UDI-DIDate30 Mar 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
105-023622-00、105-023623-00、105-023624-00、105-023625-00、105-023626-00、105-023627-00, 105-023622-00, 105-023627-00
Primary DI / UDI-DI
06903053025409, 06903053025454
Basic UDI-DI
69449040AB75000065V
EMDN Code
W0103020201 Fibrinogen assays (factor i)
Device Class
Class C
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000014156
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Shenzhen Mindray Bio-Medical Electronics Co., LTD

See all devices from Shenzhen Mindray Bio-Medical Electronics Co., LTD →

Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
  • Reagent
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (2)

  • EUDAMED 1971f1bf-c2fd-486c-893f-b94ee8f6a00f 61 fields · synced 22 Oct 2026
  • EUDAMED 5faca481-46e6-4784-a41d-2d4149f776ca 61 fields · synced 18 May 2026