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E7GENPRO

by FAMID Biomedical Technology (Tianjin) Co., Ltd. China EUDAMED

Ref F3027

EMDN W01010230

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-16972838809203 Basic UDI-DIDate27 Feb 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 24 Oct 2026

Device Name
E7 Protein Test Kit (Colloidal Gold Method)
Model / Reference
F3027
Primary DI / UDI-DI
16972838809203
Basic UDI-DI
B-16972838809203
EMDN Code
W01010230 Total protein
Device Class
Class IVD General
Market of Registration
Poland

Manufacturer details

EUDAMED SRN
CN-MF-000051665
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from FAMID Biomedical Technology (Tianjin) Co., Ltd.

Properties & raw data

Show properties, registry sources and raw records
  • Reagent
  • Self Testing
  • Near-Patient Testing
  • Professional Testing
  • Companion Diagnostics
Other properties (5)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED da3ab365-4838-4520-a096-25a637dcce57 61 fields · synced 24 Oct 2026