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iGFBP-1 Rapid Test

by Zhuhai Encode Medical Engineering Co., Ltd. China EUDAMED

Ref FIG-5022Model card -type: 2 Tests/Kit

EMDN W0102060405

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06974566302400 Basic UDI-DIDate12 May 2026RegisteredStatusActive

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

Model / Reference
card -type: 2 Tests/Kit, FIG-5022
Primary DI / UDI-DI
06974566302400
Basic UDI-DI
B-06974566302400
EMDN Code
W0102060405 Insulin-like growth factor binding protein 1
Device Class
Class IVD General
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000019361
Authorised representative
Medunion S.L. ES-AR-000019366

Other devices from Zhuhai Encode Medical Engineering Co., Ltd.

See all devices from Zhuhai Encode Medical Engineering Co., Ltd. →

Properties & raw data

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

Sources (1)

  • EUDAMED 5f634d93-0c9d-4f0d-82d1-1956115db131 61 fields · synced 22 Oct 2026