ALBA 4D

Organization name

Med-Logix Srl

SRN

IT-MF-000026525

Manufacturer status

Active

2 warnings recorded — scroll inside the panel to see all entries.

• CW010

  EUDAMED did not publish a description for this code.
• CW018

  EUDAMED did not publish a description for this code.

Primary placement in Spain; available across 1 country total.

Trade name

not provided

UDI-DI code

08052109160019

Basic UDI-DI

8052109160101U4

Reference / catalog number

ALBA 4D

Issuing entity

GS1

Risk category

Class IIb

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product 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.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• 70000000 MU27
• Power — 0–2000 MU103

European Medical Device Nomenclature — the EU product classification assigned to this device.

• Z1204021501MULTI-DISTRICT ONCOLOGICAL HYPERTHERMIA EQUIPMENT

Certificate health across this manufacturer's portfolio.