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SuperFlex uE3 Kit

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

Ref SY488QGModel 100 tests

EMDN W0102050203

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69510458SF_uE33B Basic UDI-DIDate5 May 2026RegisteredStatusActive

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 uE3 Kit
Model / Reference
100 tests, SY488QG
Primary DI / UDI-DI
06951045811516
Basic UDI-DI
69510458SF_uE33B
EMDN Code
W0102050203 Unconjugated (free) estriol
Device Class
Class C
Market of Registration
Netherlands

Manufacturer details

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

Properties & raw data

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

Sources (1)

  • EUDAMED 19fad570-8ea7-4ae2-85ac-85ea7ffc1e44 61 fields · synced 22 Oct 2026