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E7GENPRO

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

Ref F3026, F3028

EMDN W01010230

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06972838809190 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
F3026, F3028
Primary DI / UDI-DI
06972838809190, 16972838809210
Basic UDI-DI
B-06972838809190, B-16972838809210
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 (2)

  • EUDAMED 84c66892-4a94-4fa6-a7ce-b4034f80387d 61 fields · synced 24 Oct 2026
  • EUDAMED 16972838809210|B-16972838809210 61 fields · synced 19 May 2026