Skip to content

Coagulation Analyzer Sample Diluent（CASD）

by Maccura Biotechnology Co., Ltd. China EUDAMED

Ref BL2101503Model 10.0 mL×12, 20.0 mL×12

EMDN W0103020199

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69506174BL21050372 Basic UDI-DIDate14 Feb 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
General Name: Coagulation Analyzer Sample Diluent（CASD)
Model / Reference
10.0 mL×12, 20.0 mL×12, BL2101503
Primary DI / UDI-DI
06950617416821
Basic UDI-DI
69506174BL21050372
Direct Marketing DI
06950617416821
EMDN Code
W0103020199 General coagulation tests - other
Device Class
Class A
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
CN-MF-000014618
Authorised representative
Humiss International B.V. NL-AR-000001490

Other devices from Maccura Biotechnology Co., Ltd.

See all devices from Maccura Biotechnology Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Reagent
  • Professional Testing
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED db0e4caa-c56c-4dfb-a1ce-5fca09dcc085 61 fields · synced 22 Oct 2026