Identity
- Trade Name
- SOLO DR 3543W2 EUDAMED
- Device Name
- Flat Panel Digital X-Ray Detector EUDAMED
- Model / Reference
- SOLO EUDAMEDF0427E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04630193910198 EUDAMED
- Basic UDI-DI
- 463019391SOLODetectorsS3 EUDAMED
- Direct Marketing DI
- 04630193910198 EUDAMED
- EMDN Code
- Z11031180 SYSTEMS FOR DIRECT DIGITAL RADIOLOGY (DR) - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Solo Dr 3543w2 by MEDICAL TECHNOLOGIES Ltd — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 463019391SOLODetectorsS3 | Class IIa | Active |
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Manufacturer
- Manufacturer
- MEDICAL TECHNOLOGIES Ltd
- EUDAMED SRN
- RU-MF-000020612
- Authorised Representative
- mdi Europa GmbH DE-AR-000006218
Sources (1)
- EUDAMED c9cd04f0-7a00-483e-94cc-9db3a6889554 61 fields · synced Jul 20, 2026