Eu Mdd
Eu Md Class 2b
On The Market
🇰🇷 South Korea
ZEN-2090Pro(ZEN-CX2090, ZEN-2090 Turbo, XENO-360)
Devices (same UDI-DI)
1
Certificates
1
Countries
2
Notified Bodies
1
Basic Information
- Primary DI
- 08809244060021
- Basic UDI-DI Code
- B-08809244060021
- Reference
- 111
- Device Types
- None provided
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2b
- Status
- On The Market
- Manufacturer
- GENORAY CO., Ltd.
Additional Description
Fluoroscope X-ray system
CND Nomenclature Codes
| Code | Description |
|---|---|
| Z11039009 | FLUOROSCOPY DEVICES |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | 10001-2017-CE-KOR-NA-PS Rev. 9.0 | DNV Product Assurance AS |
Available In Countries
🇮🇪 Ireland
🇵🇱 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