Devices (same UDI-DI)
1
Certificates
1
Countries
2
Notified Bodies
1
Let the assistant research this device
The Research Assistant compiles risk class, certificates, notified bodies and related records — and cites every one.
Free to try · every answer cites its records
Basic Information
- Primary DI
- 08800042100018
- Basic UDI-DI Code
- B-08800042100018
- Reference
- BIOXEL
- Device Types
- None provided
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2b
- Status
- On The Market
- Manufacturer
- AMI INC.
Additional Description
Surgical Laser system using 10600nm CO2 Laser
CND Nomenclature Codes
| Code | Description |
|---|---|
| Z12011005 | CARBON DIOXIDE 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
🇱🇹 Lithuania
🇵🇱 Poland
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