Eu Mdd
Eu Md Class 2a
On The Market
๐ฎ๐ฑ Israel
Sheerwave
Devices (same UDI-DI)
1
Certificates
1
Countries
16
Notified Bodies
1
Basic Information
- Primary DI
- 07290016727043
- Basic UDI-DI Code
- B-07290016727043
- Reference
- IPL-360
- Device Types
- None provided
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2a
- Status
- On The Market
- Manufacturer
- Active Optical Systems Ltd
Additional Description
The Extra - 818 is a Photothermolysis and phototherapy device. it is a hair removal device based on light energy. The clinical indication is treatment aimed to elevate the symptoms of Hirsutism. The Extra - 818 can perform as well, aesthetical hair removal. In addition, it is used for general dermatological uses such as Acne reduction, skin rejuvenation, Pigmentation and vascular lightening. The treatment is not invasive and is performed on top of healthy skin.
CND Nomenclature Codes
| Code | Description |
|---|---|
| Z12040202 | PHOTOTHERAPY EQUIPMENT |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex V | 07290016727043 | MDC MEDICAL DEVICE CERTIFICATION GMBH | Expired |
Available In Countries
๐ง๐ช Belgium
๐ง๐ฌ Bulgaria
๐จ๐พ Cyprus
๐จ๐ฟ Czechia
๐ฉ๐ช Germany
๐ฌ๐ท Greece
๐ช๐ธ Spain
๐ซ๐ฎ Finland
๐ซ๐ท France
๐ญ๐บ Hungary
๐ฎ๐น Italy
๐ฑ๐น Lithuania
๐ฒ๐น Malta
๐ณ๐ฑ Netherlands
๐ธ๐ช Sweden
๐น๐ท Tรผrkiye
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