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RAPIXX DR-System 4336M1F ES CC Set

by PROTEC X-ray Systems GmbH EUDAMED

Active European Union

Ref 4999-9-0000_V008

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number426050264D001UX Basic UDI-DIDate6 May 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  • Withdrawn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

Device Name
RAPIXX DR-System
Model / Reference
4999-9-0000_V008
Primary DI / UDI-DI
04260502643587
Basic UDI-DI
426050264D001UX
EMDN Code
Z11031101 Multifunctional systems for direct digital radiology
Device Class
Class IIb
Medical Purpose
The digital X-ray detector systems of the RAPIXX series are intended as system components of diagnostic X-ray systems for the acquisition, image processing, and data transmission of conventional X-ray images for various routine applications in planar X-ray imaging in human medicine. RAPIXX DR systems are not intended for use in mammography or the dental field.

Manufacturer details

EUDAMED SRN
DE-PR-000048508

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Properties

Show properties
Other properties (1)
  • Sterile: No