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D-Dimer Calibrator

by Maccura Biotechnology Co., Ltd. China EUDAMED

Ref EBL2183005, EBL2182005, EBL2181005

EMDN W0103020701

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-EBL2183005AA 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
D-Dimer Calibrator
Model / Reference
EBL2183005, EBL2182005, EBL2181005
Primary DI / UDI-DI
D-EBL2183005AA, D-EBL2182005A3, D-EBL21810059U
Basic UDI-DI
B-EBL2183005AA, B-EBL2182005A3, B-EBL21810059U
EMDN Code
W0103020701 Calibration plasma for haemostasis
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
  • Microbial Substances
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Human Tissues: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (3)

  • EUDAMED 80b5118a-b485-41e8-b744-9bb585aa6f2b 61 fields · synced 22 Oct 2026
  • EUDAMED D-EBL2182005A3|B-EBL2182005A3 61 fields · synced 17 May 2026
  • EUDAMED D-EBL21810059U|B-EBL21810059U 61 fields · synced 18 May 2026