Skip to content

Primax Rdx-58 E

by SKYDENT, a.s. Slovakia EUDAMED

Ref 51456

EMDN Z130104

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08588003514561 Basic UDI-DIDate21 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/MDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Primax Rdx-58 E
Model / Reference
51456
Primary DI / UDI-DI
08588003514561
Basic UDI-DI
B-08588003514561
EMDN Code
Z130104 Endoral dental x-ray films
Device Class
Class IIa
Market of Registration
Slovakia

Manufacturer details

EUDAMED SRN
SK-MF-000044434

Other devices from SKYDENT, a.s.

See all devices from SKYDENT, a.s. →

Properties & raw data

Show properties, registry sources and raw records
Other properties (11)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 213b8392-448d-4910-815e-438dc158f60c 61 fields · synced 22 Oct 2026