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PLAU/SPP1/MMP1 Gene Detection Kit (Fluorescent PCR)

by Shanghai Focusgen Biotechnology Co., Ltd EUDAMED

Active European Union

Ref 48 tests/box

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06977738300006 Basic UDI-DIDate6 Dec 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
PLAU/SPP1/MMP1 Gene Detection Kit (Fluorescent PCR)
Model / Reference
48 tests/box
Primary DI / UDI-DI
06977738300006
Basic UDI-DI
B-06977738300006
EMDN Code
W0102010110 Immunoelectrophoresis kits
Device Class
Class IVD General
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000044043
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Shanghai Focusgen Biotechnology Co., Ltd

Properties

Show properties
  • 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