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Prostatic Exosomal Protein Quantitative Detection Kit (Fluorescence lmmunochromatography)

by Onco Biomedical Technology (Suzhou) Co., Ltd. China EUDAMED

Ref PSEP-1030001T

EMDN W0102019007

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-69328692FI001MCGK Basic UDI-DIDate23 May 2025RegisteredStatusActive

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
PSEP-1030001T
Primary DI / UDI-DI
D-69328692FI001MCGK
Basic UDI-DI
B-69328692FI001MCGK
EMDN Code
W0102019007 Immuno reactive trypsin
Device Class
Class IVD General
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000047590
Authorised representative
MedPath GmbH DE-AR-000000087

Other devices from Onco Biomedical Technology (Suzhou) 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 f2c3ad93-e895-41a0-b541-d7bc7f699e15 61 fields · synced 22 Oct 2026