SDX System 3.0

Organization name

DYN'R

SRN

FR-MF-000001876

Manufacturer status

Active

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

• CW010

  EUDAMED did not publish a description for this code.
• CW011

  EUDAMED did not publish a description for this code.
• CW999

  Not to be disposed of household waste.

Primary placement in France; available across 12 countries total.

Trade name

SDX System 3.0

UDI-DI code

03760290230002

Basic UDI-DI

B-03760290230002

Reference / catalog number

SDX0306V3.0

Issuing entity

GS1

Risk category

Class IIb

Applicable legislation

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

The SDX System is intended for use in Radiation Therapy as an aid in allowing the patient and treatment staff to visualize a patient breathing process and to optimize breathing to limit internal motion during imaging & treatment. The target population are patients who suffer from cancers in the thoraco-abdominal region and require radiation imaging and treatment, and capable of understanding and following the radiotherapist’s instructions.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• Z11019099VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - OTHER

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification