Skip to content

SuperFlex Free hCGβ Kit

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

Ref SY460QGModel 100 tests EMDN W0102050213

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69510458SF_FreeHCGBLF Basic UDI-DIDate5 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
SuperFlex Free hCGβ Kit
Model / Reference
100 tests, SY460QG
Primary DI / UDI-DI
06951045811509
Basic UDI-DI
69510458SF_FreeHCGBLF
EMDN Code
W0102050213 Free beta hcg (prenatal screening)
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
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 07cf669b-8337-45bb-bd03-62340a141a56 61 fields · synced 24 Oct 2026