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E7 Oncoprotein Rapid Test Kit

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

Ref F3037

EMDN W0102160299

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697283880F3037DA Basic UDI-DIDate2 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • C899023 Issued

    Technical documentation EU IVDR

    Notified body
    DNV Product Assurance AS 2460
    Issued
    1 Oct 2026
    Expires
    29 Sep 2031

Specification

EUDAMED · synced 25 Oct 2026

Model / Reference
F3037
Primary DI / UDI-DI
06972838800067
Basic UDI-DI
697283880F3037DA
Direct Marketing DI
06972838800067
EMDN Code
W0102160299 Tumour marker rt & poc - other
Device Class
Class C
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
  • Animal Tissues
  • Reagent
  • Self Testing
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 06972838800067|697283880F3037DA 61 fields · synced 25 Oct 2026