Skip to content

RadioDtect

by NEOLYS Diagnostics EUDAMED

Active European Union

Ref RadioDtect

Overview

Introducing RadioDtect, a cutting-edge medical device that utilizes Neolys Diagnostics technology to detect abnormalities in patient tissue samples. By providing accurate and reliable results, RadioDtect has revolutionized the field of medical diagnostics.

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-RadioDtect4Z Basic UDI-DIDate16 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Expiring

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Model / Reference
RadioDtect
Primary DI / UDI-DI
D-RadioDtect4Z
Basic UDI-DI
B-RadioDtect4Z
EMDN Code
W0102019099 Specific proteins - other
Device Class
Class IVD General
Special Device Type
-1202
Market of Registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000036165

Other devices from NEOLYS Diagnostics

Properties

  • Professional Testing

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
  • Surgical Instrument: No