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Thrombin Time (TT)

by Maccura Biotechnology Co., Ltd. China EUDAMED

Ref EBL2110003, EBL2111003 , EBL2112003, EBL2113003

EMDN W0103020103

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-EBL211000374 Basic UDI-DIDate22 May 2022RegisteredStatusActive

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 22 Oct 2026

Device Name
Thrombin Time (TT)
Model / Reference
EBL2110003, EBL2111003, EBL2112003, EBL2113003
Primary DI / UDI-DI
D-EBL211000374, D-EBL21110037B, D-EBL21120037J, D-EBL21130037R
Basic UDI-DI
B-EBL211000374, B-EBL21110037B, B-EBL21120037J, B-EBL21130037R
EMDN Code
W0103020103 Thrombin time / reptilase / batroxobin time
Device Class
Class IVD General
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000014618
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

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
  • Animal Tissues
  • Reagent
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (4)

  • EUDAMED b9d5957d-68e1-427a-b9b9-7d98dc70e7fe 61 fields · synced 22 Oct 2026
  • EUDAMED D-EBL21110037B|B-EBL21110037B 61 fields · synced 17 May 2026
  • EUDAMED D-EBL21120037J|B-EBL21120037J 61 fields · synced 18 May 2026
  • EUDAMED D-EBL21130037R|B-EBL21130037R 61 fields · synced 19 May 2026