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Digital Diagnostic Radiography System
EUDAMEDClass IIb (EU MDR)
Ref SONTU100-Polaris50 EModel SONTU100-Polaris50E
Identity
- Device Name
- Digital Diagnostic Radiography System EUDAMED
- Model / Reference
- SONTU100-Polaris50E EUDAMEDSONTU100-Polaris50 E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973074990031 EUDAMED
- Basic UDI-DI
- B-06973074990031 EUDAMED
- EMDN Code
- Z11031101 MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Stationary basic diagnostic x-ray system, digital
Digital Diagnostic Radiography System by Shenzhen SONTU Medical Imaging Equipment Co., LTD — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06973074990031 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Shenzhen SONTU Medical Imaging Equipment Co., LTD
- EUDAMED SRN
- CN-MF-000006958
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED bc697a0a-4028-49df-9a5c-8d253e32ba3b 61 fields · synced Jun 19, 2026