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Thromboelastographic Platelet Assay (AA/ADP)

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

Ref MCT00512E

EMDN W0103020401

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberB-06926802603772 Basic UDI-DIDate29 Sep 2026RegisteredStatusActive
European UnionCE/IVDD NumberB-06926802603772 Basic UDI-DIDate29 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR, CE/IVDD Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Device Name
Thromboelastographic Platelet Assay (AA/ADP)
Thromboelastographic Platelet Assay(AA/ADP)
Model / Reference
MCT00512E
Primary DI / UDI-DI
06926802603772
Basic UDI-DI
B-06926802603772, 69268026MD66D00001WZ
EMDN Code
W0103020401 Aggregation reagents
Device Class
Class IVD General
Class C
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
  • 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 (2)

  • EUDAMED 06926802603772|B-06926802603772 61 fields · synced 25 Oct 2026
  • EUDAMED 06926802603772|69268026MD66D00001WZ 61 fields · synced 25 Oct 2026