← Back to catalogue
RAPIXX DR-System 4336M2F ES WiFi Set
EUDAMEDClass IIb (EU MDR)
Ref 4999-9-0000_V005
Identity
- Trade Name
- RAPIXX DR-System 4336M2F ES WiFi Set EUDAMED
- Device Name
- RAPIXX DR-System EUDAMED
- Model / Reference
- 4999-9-0000_V005 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260502643556 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 WiFi Set by PROTEC X-ray Systems GmbH — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Stationary basic diagnostic x-ray system, digital.
- EXSYS DEXi — Drtech Corp. · Class II
- DX-D 400 — Agfa Corp. · Class II
- DRX - Ascend System — CARESTREAM HEALTH, INC. · Class II
- CARESTREAM DRX-EVOLUTION — CARESTREAM HEALTH, INC. · Class II
- DRX - Ascend System — CARESTREAM HEALTH, INC. · Class II
- SEDECAL — Sedecal., Sa. · Class II
- Q-RAD System — CARESTREAM HEALTH, INC. · Class II
- iDR603V-110 — YIAN MEDICAL TECHNOLOGY (HAINING) CO., LTD. · Class IIb
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 |
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 81efcff4-16e0-47db-bb41-5fe17b6ae6d1 61 fields · synced Jun 19, 2026