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SuperFlex D-Dimer Kit

by Suzhou Sym-Bio Lifescience Co., Ltd. China EUDAMED

Ref SDX-57036Model 50 tests

EMDN W0103020503

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69510458SF_D-DimerR7 Basic UDI-DIDate1 Jul 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
SuperFlex D-Dimer Kit
Model / Reference
50 tests, SDX-57036
Primary DI / UDI-DI
06951045810113
Basic UDI-DI
69510458SF_D-DimerR7
EMDN Code
W0103020503 D-dimer
Device Class
Class C
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
CN-MF-000012847
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from Suzhou Sym-Bio Lifescience Co., Ltd.

See all devices from Suzhou Sym-Bio Lifescience Co., Ltd. →

Properties & raw data

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

Sources (1)

  • EUDAMED 531eb682-03ff-424f-903d-7d9555d25da6 61 fields · synced 22 Oct 2026