Eu Mdd Eu Md Class 2b On The Market 🇫🇷 France

SDX System

DYN'R · 🇫🇷 France
Devices (same UDI-DI)
1
Certificates
1
Countries
12
Notified Bodies
1

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Basic Information

Primary DI
03760290230002
Basic UDI-DI Code
B-03760290230002
Reference
SDX0306V3.0
Device Types
None provided
Regulation
Eu Mdd
Classification
Eu Md Class 2b
Status
On The Market
Manufacturer
DYN'R

Additional 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.

CND Nomenclature Codes

Code Description
Z11019099 VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - OTHER

Certificates

Type Number
MDD Annex II (excluding section 4) 15913

Available In Countries

🇦🇹 Austria 🇧🇪 Belgium 🇨🇿 Czechia 🇩🇪 Germany 🇪🇸 Spain 🇫🇷 France 🇮🇪 Ireland 🇮🇹 Italy 🇱🇺 Luxembourg 🇳🇱 Netherlands 🇵🇹 Portugal 🇬🇧 United Kingdom

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