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RAPIXX DR-System 4336M1i X WiFi Set

by PROTEC X-ray Systems GmbH 5 variants

Ref 4999-9-0000_V017

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number426050264D001UX Basic UDI-DI 04260502643662UDI-DIDate6 May 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
RAPIXX DR-System
Model / Reference
4999-9-0000_V017
Primary DI / UDI-DI
04260502643662
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

Other properties (1)

  • Sterile: No