Eu Mdd
Eu Md Class 2b
No Longer On The Market
🇰🇷 South Korea
Sonotrip V20
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- 08800020101877
- Basic UDI-DI Code
- B-08800020101877
- Reference
- 17
- Device Types
- None provided
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2b
- Status
- No Longer On The Market
- Manufacturer
- Jeisys Medical Inc.
Additional Description
High Intensity Focused Ultrasound Therapeutic System is intended for a non-invasive treatment method using high-intensity ultrasound heat focusing on one point of the lesion and, necrotizes or ablates tumor tissue. (Specific indication for use: uterine myoma/fibroid)
CND Nomenclature Codes
| Code | Description |
|---|---|
| Z120610 | ULTRASOUND THERAPY EQUIPMENT |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | 0068/QCO-DM/310-2021 | MTIC InterCert S.r.l. |
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