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SuperFlex D-Dimer Control

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

Ref SDX-57037Model Level 1: 1.2mL×4, Level 2: 1.2mL×4

EMDN W0103030499

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06951045810427 Basic UDI-DIDate15 Sep 2025RegisteredStatusActive

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
SuperFlex D-Dimer Control
Model / Reference
Level 1: 1.2mL×4, Level 2: 1.2mL×4, SDX-57037
Primary DI / UDI-DI
06951045810427
Basic UDI-DI
B-06951045810427
EMDN Code
W0103030499 Immunohaematology controls - other
Device Class
Class IVD General
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
  • Professional Testing
Other properties (6)
  • Sterile: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 620b343c-317a-48bf-9624-8e1649edb696 61 fields · synced 22 Oct 2026