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Dry Fluorescence Immunoassay Analyzer

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

Ref AK-Q100

EMDN W0102019007

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69328692DA001JW Basic UDI-DIDate23 May 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
AK-Q100
Primary DI / UDI-DI
16932869200110
Basic UDI-DI
69328692DA001JW
Direct Marketing DI
16932869200110
EMDN Code
W0102019007 Immuno reactive trypsin
Device Class
Class A
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
  • Professional Testing
  • Surgical Instrument
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • New Device: No

Sources (1)

  • EUDAMED dca1f0f9-7aaf-4ff8-bfc0-b475382f5caf 61 fields · synced 22 Oct 2026