Devices (same UDI-DI)
1
Certificates
1
Countries
6
Notified Bodies
1
Basic Information
- Primary DI
- 07290018152003
- Basic UDI-DI Code
- B-07290018152003
- Reference
- FG00001INT
- Device Types
- None provided
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2a
- Status
- On The Market
- Manufacturer
- Sofwave Medical Ltd.
Additional Description
The Sofwave is indicated for use as a non-invasive dermatological aesthetic treatment to improve facial lines and wrinkles for subjects aged 22 and older. The intended clinical performance of Sofwave is improvement of facial lines and wrinkles.
CND Nomenclature Codes
| Code | Description |
|---|---|
| Z120610 | ULTRASOUND THERAPY EQUIPMENT |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | 3902551CE01 | DEKRA Certification B.V. | Expired |
Available In Countries
๐ฉ๐ช Germany
๐ช๐ธ Spain
๐ซ๐ท France
๐ฎ๐น Italy
๐ต๐ฑ Poland
๐น๐ท Tรผrkiye
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