Eu Mdd
Eu Md Class 2b
On The Market
๐จ๐ฆ Canada
Sonalleve
Devices (same UDI-DI)
1
Certificates
1
Countries
25
Notified Bodies
1
Basic Information
- Primary DI
- 07540281000236
- Basic UDI-DI Code
- B-07540281000236
- Reference
- 451000080766
- Device Types
- None provided
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2b
- Status
- On The Market
- Manufacturer
- Profound Medical Inc.
Additional Description
The Sonalleve Magnetic Resonance Imaging -guided High Intensity Focused Ultrasound (MR-HIFU) system is designed to non-invasively deliver acoustic energy to prescribed locations. The system integrates a high intensity phased-array focused ultrasound transducer with an MR imaging system and electromechanical transducer positioning system to deliver spatially and temporally controlled ultrasound energy to elevate tissue temperatures.
CND Nomenclature Codes
| Code | Description |
|---|---|
| Z1204021501 | MULTI-DISTRICT ONCOLOGICAL HYPERTHERMIA EQUIPMENT |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | CE 601642 | BSI Group The Netherlands B.V. | Expired |
Available In Countries
๐ฆ๐น Austria
๐ง๐ช Belgium
๐ง๐ฌ Bulgaria
๐จ๐ฟ Czechia
๐ฉ๐ช Germany
๐ฉ๐ฐ Denmark
๐ช๐ช Estonia
๐ฌ๐ท Greece
๐ช๐ธ Spain
๐ซ๐ฎ Finland
๐ซ๐ท France
๐ญ๐บ Hungary
๐ฎ๐ช Ireland
๐ฎ๐ธ Iceland
๐ฎ๐น Italy
๐ฑ๐ฎ Liechtenstein
๐ฑ๐น Lithuania
๐ฑ๐บ Luxembourg
๐ฑ๐ป Latvia
๐ณ๐ฑ Netherlands
๐ณ๐ด Norway
๐ต๐ฑ Poland
๐ท๐ด Romania
๐ธ๐ช Sweden
๐ธ๐ฎ Slovenia
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