Eu Mdd
Eu Md Class 2b
On The Market
๐ฐ๐ท South Korea
REX-AN DUAL
Devices (same UDI-DI)
1
Certificates
1
Countries
3
Notified Bodies
1
Basic Information
- Primary DI
- 08800042100087
- Basic UDI-DI Code
- B-08800042100087
- Reference
- AMI-CL-0621
- Device Types
- None provided
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2b
- Status
- On The Market
- Manufacturer
- AMI INC.
Additional Description
The device has wavelengths of 755nm and 1064nm for the treatment of a pigmented and vascular lesions.
CND Nomenclature Codes
| Code | Description |
|---|---|
| Z12011012 | DYE/ALEXANDRITE SURGICAL LASER |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | 0068/QCO-DM/074-2017 | MTIC InterCert S.r.l. | Expired |
Available In Countries
๐ญ๐บ Hungary
๐ฑ๐น Lithuania
๐ต๐ฑ Poland
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