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RAPIXX DR-System 4336M2F ES CC Set
EUDAMEDClass IIb (EU MDR)
Ref 4999-9-0000_V009
Identity
- Trade Name
- RAPIXX DR-System 4336M2F ES CC Set EUDAMED
- Device Name
- RAPIXX DR-System EUDAMED
- Model / Reference
- 4999-9-0000_V009 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260502643594 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
Category: Stationary basic diagnostic x-ray system, digital
RAPIXX DR-System 4336M2F ES CC Set by PROTEC X-ray Systems GmbH — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 426050264D001UX | Class IIb | Active |
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Manufacturer
- Manufacturer
- PROTEC X-ray Systems GmbH
- EUDAMED SRN
- DE-PR-000048508
Sources (1)
- EUDAMED 83caebbd-2ce3-401f-816e-64ea717e109b 61 fields · synced Jul 14, 2026