Identity
- Trade Name
- SWISSRAD SB-4 EUDAMED
- Device Name
- SWISSRAD EUDAMED
- Model / Reference
- 8000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07649993341054 EUDAMED
- Basic UDI-DI
- 7649993341SWISSRADAA EUDAMED
- EMDN Code
- Z11031101 MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Medical Purpose
- The system is a medical radiology workstation. The system enables all X-rays to be taken on the standing, sitting or lying patient to examine the skeleton, thorax and abdomen. EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Category: Stationary basic diagnostic x-ray system, digital
Swissrad Sb-4 by MDTS medtechsolutions AG — 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 | 7649993341SWISSRADAA | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- MDTS medtechsolutions AG
- EUDAMED SRN
- DE-PR-000027569
Sources (1)
- EUDAMED 9f910b24-0b16-450b-b967-db0022334fac 61 fields · synced Aug 4, 2026