← Back to catalogue

RAPIXX DR-System 4343M2F ES CC Set

EUDAMED

Class IIb (EU MDR)

Ref 4999-9-0000_V011

by PROTEC X-ray Systems GmbH

Identity

Trade Name
RAPIXX DR-System 4343M2F ES CC Set EUDAMED
Device Name
RAPIXX DR-System EUDAMED
Model / Reference
4999-9-0000_V011 EUDAMED

Identifiers

Primary DI / UDI-DI
04260502643617 EUDAMED
Basic UDI-DI
426050264D001UX EUDAMED
EMDN Code
Z11031101 MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY EUDAMED

Classification

Device Class
Class IIb EUDAMED
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. EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

RAPIXX DR-System 4343M2F ES CC Set by PROTEC X-ray Systems GmbH — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
PROTEC X-ray Systems GmbH
EUDAMED SRN
DE-PR-000048508

Sources (1)

  • EUDAMED c9de54d8-ae0c-4938-9f0a-768196e698a0 61 fields · synced Jul 9, 2026