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HER2/CEP17 Dual Color CISH Probe

by Shenzhen Dartmon Biotechnology Co., Ltd. EUDAMED

Active European Union

Ref DMRD0581

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06927210914108 Basic UDI-DIDate29 Jun 2026RegisteredStatusActive

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  • Withdrawn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

Model / Reference
DMRD0581
Primary DI / UDI-DI
06927210914108, 06927210914115, 06927210914122, 06927210914139
Basic UDI-DI
B-06927210914108, B-06927210914115, B-06927210914122, B-06927210914139
EMDN Code
W01060213 Her-2/neu (breast cancer)
Device Class
Class IVD General
Market of Registration
Greece

Manufacturer details

EUDAMED SRN
CN-MF-000019183
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Shenzhen Dartmon Biotechnology Co., Ltd.

See all devices from Shenzhen Dartmon Biotechnology Co., Ltd. →

Properties

Show properties
  • Animal Tissues
  • Reagent
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No