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SuperFlex Procalcitonin Kit

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

Ref SDX-57003/SDX-57032Model 100 tests/ 50 tests EMDN W0102069013

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69510458SF_PCTY2 Basic UDI-DIDate23 Dec 2021RegisteredStatusActive

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  • Withdrawn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
SuperFlex Procalcitonin Kit
Model / Reference
100 tests/ 50 tests, SDX-57003/SDX-57032
Primary DI / UDI-DI
06951045810021
Basic UDI-DI
69510458SF_PCTY2
Unit of Use DI
06951045810120
EMDN Code
W0102069013 Procalcitonin
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
  • 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 58fbc59b-74b4-4938-b6cc-8626ed7f9a7a 61 fields · synced 22 Oct 2026