Eu Mdd
Eu Md Class 2b
On The Market
🇰🇷 South Korea
Chungwoo Co., Ltd.
Devices (same UDI-DI)
1
Certificates
1
Countries
1
Notified Bodies
1
Basic Information
- Primary DI
- 08809495930364
- Basic UDI-DI Code
- B-08809495930364
- Reference
- [EM 007(930M)_R3] CWM-930M User manual
- Device Types
-
Single use Sterile
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2b
- Status
- On The Market
- Manufacturer
- Chungwoo Co., Ltd.
Additional Description
This device is Fractional RF Surgical Unit composed of main device, hand piece, foot switch and micro needle electrodes. And it is designed for applying radio frequency therapy with micro needles. By using micro needle, it coagulates the tissue for acne scar treatment.
CND Nomenclature Codes
| Code | Description |
|---|---|
| K020380 | DEVICES FOR SURGERY WITH RADIOFREQUENCY GENERATOR, SINGLE-USE - ACCESSORIES |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | 2018-MDD/QS-013 | 3EC International a.s. | Expired |
Available In Countries
🇮🇹 Italy
Similar Devices
Other on-the-market devices with the same classification (Eu Md Class 2b) and regulation (EU MDD).
Horizontal Steam Sterilizer
Device
EU MDD
·
Eu Md Class 2b
·PROHS Equipamento Hospitalar e Serviços Associados S.A.·On the market·10 countries
Adacolumn
Device
EU MDD
·
Eu Md Class 2b
·JIMRO Co., Ltd.·On the market·9 countries
Echopulse
Device
EU MDD
·
Eu Md Class 2b
·Theraclion·On the market·8 countries
Echopulse
Device
EU MDD
·
Eu Md Class 2b
·Theraclion·On the market·7 countries
Sonovein
Device
EU MDD
·
Eu Md Class 2b
·Theraclion·On the market·6 countries
Mevion S250i
Device
EU MDD
·
Eu Md Class 2b
·Mevion Medical Systems, Inc.·On the market·1 country