EU Manufacturer
๐จ๐ญ Switzerland
Active
Bien-Air Surgery SA
SRN: CH-MF-000016376
ยท
Rue de l'Ouest 2B, 2340 Le Noirmont, Switzerland
Basic UDI-DIs
3
Total Devices
8
On Market
7
Off Market
1
Certificates
0
Valid
0
Expiring < 6mo
0
Countries
18
Basic Information
- Address
- Rue de l'Ouest 2B, 2340 Le Noirmont, Switzerland
- [email protected]
- Website
- https://surgery.bienair.com/
Regulatory Overview
Regulation
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Eu Mdr
3
Classification
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Eu Md Class 1
2
Eu Md Class 2a
1
Device Types
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Certificate Health
No certificates registered for this manufacturer.
Market Presence
Devices from this manufacturer are available in 18 countries across Europe.
๐ฆ๐น Austria
๐ง๐ช Belgium
๐ง๐ฌ Bulgaria
๐จ๐ฟ Czechia
๐ฉ๐ช Germany
๐ช๐ช Estonia
๐ฌ๐ท Greece
๐ช๐ธ Spain
๐ซ๐ฎ Finland
๐ซ๐ท France
๐ฎ๐ช Ireland
๐ฎ๐น Italy
๐ฑ๐น Lithuania
๐ณ๐ฑ Netherlands
๐ต๐ฑ Poland
๐ต๐น Portugal
๐ท๐ด Romania
๐ธ๐ช Sweden
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| E-type Sterilization Tray | EU MDR | Eu Md Class 1 | On Market | 0 |
| ORIGO Control Unit | EU MDR | Eu Md Class 2a | On Market | 0 |
| ORIGO Foot Pedal | EU MDR | Eu Md Class 1 | On Market | 0 |
| OSSEOSTAP Sterilization Tray | EU MDR | Eu Md Class 1 | On Market | 0 |
| PM2 Sterilization Tray 300025 | EU MDR | Eu Md Class 1 | Not EU | 0 |
| PM2 Sterilization Tray ENT | EU MDR | Eu Md Class 1 | On Market | 0 |
| PM2 Sterilization Tray Neuro | EU MDR | Eu Md Class 1 | On Market | 0 |
| S120 Sterilization Tray | EU MDR | Eu Md Class 1 | On Market | 0 |