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TheraDose

by Comecer Netherlands B.V. Netherlands EUDAMED

Ref 0246110001Model TheraDose EMDN Z11029099

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8719324589INJSPPTD Basic UDI-DIDate9 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Model / Reference
TheraDose, 0246110001
Primary DI / UDI-DI
08719324589130
Basic UDI-DI
8719324589INJSPPTD
EMDN Code
Z11029099 Various instruments for nuclear medicine - other
Device Class
Class IIb
Medical Purpose
The TheraDose single dose vial injector is intended to inject radiopharmaceuticals contained in single-dose vials into patients in an automated and controlled manner, while reducing users’ ionizing radiation exposure.

Manufacturer details

EUDAMED SRN
NL-PR-000052795

Other devices from Comecer Netherlands B.V.

See all devices from Comecer Netherlands B.V. →

Properties & raw data

Show properties, registry sources and raw records
Other properties (1)
  • Sterile: No

Sources (1)

  • EUDAMED 08719324589130|8719324589INJSPPTD 61 fields · synced 25 Oct 2026