Devices (same UDI-DI)
1
Certificates
0
Countries
1
Notified Bodies
0
Basic Information
- Primary DI
- 08052109160019
- Basic UDI-DI Code
- 8052109160101U4
- Reference
- ALBA 4D
- Device Types
- None provided
- Regulation
- Eu Mdr
- Classification
- Eu Md Class 2b
- Status
- On The Market
- Manufacturer
- Med-Logix Srl
Additional Description
Radiative system for external loco-regional deep hyperthermia consisting of an array of antennas which, arranged around the patient, exploit the phenomenon of constructive interference of electromagnetic waves to focus the electromagnetic energy in the target volume increasing the temperature in the range 41-43 °C. The intended use of the device is in conjunction with standard radiotherapy and/or chemotherapy therapies in order to increase its effectiveness on healthy tissues, in terms of tumor response, survival, local control and quality of life, without additional toxicity.
CND Nomenclature Codes
| Code | Description |
|---|---|
| Z1204021501 | MULTI-DISTRICT ONCOLOGICAL HYPERTHERMIA EQUIPMENT |
Available In Countries
🇪🇸 Spain
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