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SuperFlex

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

Ref SUPERFLEX-CE, SDX-56343Model SuperFlex, 210mL / bottle EMDN W0201020101

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69510458INST_SuperFlexXZ Basic UDI-DIDate13 May 2025RegisteredStatusActive

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  • Withdrawn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 22 Oct 2026

Device Name
Automated Chemiluminescence Analyzer
SuperFlex Trigger Solution
Model / Reference
SuperFlex, SUPERFLEX-CE, 210mL / bottle, SDX-56343
Primary DI / UDI-DI
06951045800015, 06951045890023
Basic UDI-DI
69510458INST_SuperFlexXZ, 69510458CS_TriggerXU
Direct Marketing DI
06951045800015
EMDN Code
W0201020101, W01029003
Device Class
Class A
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
  • Reagent NoEUDAMEDYesEUDAMED
  • Professional Testing
  • Surgical Instrument YesEUDAMEDNoEUDAMED
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • New Device: No

Sources (2)

  • EUDAMED 59c3fa49-07d7-418a-b2db-e5244c2c7670 61 fields · synced 22 Oct 2026
  • EUDAMED 06951045890023|69510458CS_TRIGGERXU 61 fields · synced 18 May 2026