EU Manufacturer
๐จ๐ญ Switzerland
Active
Bien-Air Dental SA
SRN: CH-MF-000014661
ยท
Lรคnggasse 60, 2504 Biel/Bienne, Switzerland
Basic UDI-DIs
12
Total Devices
134
On Market
134
Off Market
0
Certificates
1
Valid
0
Expiring < 6mo
0
Countries
32
Basic Information
- Address
- Lรคnggasse 60, 2504 Biel/Bienne, Switzerland
- [email protected]
- Website
- www.dental.bienair.com
Regulatory Overview
Regulation
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Eu Mdr
8
Eu Mdd
4
Classification
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Eu Md Class 2a
11
Eu Md Class 1
1
Device Types
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Certificate Health
Total
1
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
1
Certificates by Expiry Year
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| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| MDD Annex II (excluding section 4) | G1 065560 0002 Rev. 01 | TรV SรD Product Service GmbH | May 26, 2024 |
Market Presence
Devices from this manufacturer are available in 32 countries across Europe.
๐ฆ๐น Austria
๐ง๐ช Belgium
๐ง๐ฌ Bulgaria
๐จ๐พ Cyprus
๐จ๐ฟ Czechia
๐ฉ๐ช Germany
๐ฉ๐ฐ Denmark
๐ช๐ช Estonia
๐ฌ๐ท Greece
๐ช๐ธ Spain
๐ซ๐ฎ Finland
๐ซ๐ท France
๐ญ๐ท Croatia
๐ญ๐บ Hungary
๐ฎ๐ช Ireland
๐ฎ๐ธ Iceland
๐ฎ๐น Italy
๐ฑ๐ฎ Liechtenstein
๐ฑ๐น Lithuania
๐ฑ๐บ Luxembourg
๐ฑ๐ป Latvia
๐ฒ๐น Malta
๐ณ๐ฑ Netherlands
๐ณ๐ด Norway
๐ต๐ฑ Poland
๐ต๐น Portugal
๐ท๐ด Romania
๐ธ๐ช Sweden
๐ธ๐ฎ Slovenia
๐ธ๐ฐ Slovakia
๐น๐ท Tรผrkiye
๐ฌ๐ง United Kingdom
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| PM 1:2 | EU MDR | Eu Md Class 2a | On Market | 0 |
| Air motor AQUILON 830 SR | EU MDD | Eu Md Class 2a | On Market | 1 |
| BOARD DMCX | EU MDR | Eu Md Class 2a | On Market | 0 |
| BOARD DMX3 CAN BOX | EU MDR | Eu Md Class 2a | On Market | 0 |
| BOARD DMX3 FULL OPEN | EU MDR | Eu Md Class 2a | On Market | 0 |
| BOARD DMX3 M Bornier | EU MDR | Eu Md Class 2a | On Market | 0 |
| BOARD DMX3 M Bornier | EU MDR | Eu Md Class 2a | On Market | 0 |
| BOARD DMX3 M BtoB | EU MDR | Eu Md Class 2a | On Market | 0 |
| BOARD DMX3 M BtoB | EU MDR | Eu Md Class 2a | On Market | 0 |
| BOARD DMX3 M BtoW | EU MDR | Eu Md Class 2a | On Market | 0 |
| BOARD DMX3 MCX 100 RPM | EU MDR | Eu Md Class 2a | On Market | 0 |
| CA 1:1 | EU MDR | Eu Md Class 2a | On Market | 0 |
| CA 1:1 L | EU MDR | Eu Md Class 2a | On Market | 0 |
| CA 1:1 L Micro-Series | EU MDR | Eu Md Class 2a | On Market | 0 |
| CA 1:2.5 L | EU MDR | Eu Md Class 2a | On Market | 0 |
| CA 1:2.5 L MS | EU MDR | Eu Md Class 2a | On Market | 0 |
| CA 1:5 | EU MDR | Eu Md Class 2a | On Market | 0 |
| CA 1:5 L | EU MDR | Eu Md Class 2a | On Market | 0 |
| CA 1:5 L Micro-Series | EU MDR | Eu Md Class 2a | On Market | 0 |
| CA 20:1 | EU MDR | Eu Md Class 2a | On Market | 0 |
| CA 20:1 L | EU MDR | Eu Md Class 2a | On Market | 0 |
| CA 20:1 L KM | EU MDR | Eu Md Class 2a | On Market | 0 |
| CA 20:1 L KM Micro-Series | EU MDR | Eu Md Class 2a | On Market | 0 |
| CA 20:1 L Micro-Series | EU MDR | Eu Md Class 2a | On Market | 0 |
| CA 20:1 LKM Micro-Series | EU MDR | Eu Md Class 2a | On Market | 0 |
| CA 20:1L Micro-Series | EU MDR | Eu Md Class 2a | On Market | 0 |
| CA NOVA 1:1L | EU MDR | Eu Md Class 2a | On Market | 0 |
| CA NOVA 1:1L MS | EU MDR | Eu Md Class 2a | On Market | 0 |
| CA NOVA 1:5L | EU MDR | Eu Md Class 2a | On Market | 0 |
| CA NOVA 1:5L MS | EU MDR | Eu Md Class 2a | On Market | 0 |
| CA PRIMA 1:1 | EU MDR | Eu Md Class 2a | On Market | 0 |
| CA PRIMA 1:1 L | EU MDR | Eu Md Class 2a | On Market | 0 |
| CA PRIMA 1:1 L MS | EU MDR | Eu Md Class 2a | On Market | 0 |
| CA PRIMA 1:121 | EU MDR | Eu Md Class 2a | On Market | 0 |
| CA eLINE 1:1 L | EU MDR | Eu Md Class 2a | On Market | 0 |
| CA eLINE 1:5 L | EU MDR | Eu Md Class 2a | On Market | 0 |
| CABLE I-SURGE LED | EU MDR | Eu Md Class 2a | On Market | 0 |
| CABLE MX LED 3M | EU MDR | Eu Md Class 2a | On Market | 0 |
| CABLE MX-I LED 3RD GEN | EU MDR | Eu Md Class 2a | On Market | 0 |
| CABLE MX-i LED | EU MDR | Eu Md Class 2a | On Market | 0 |
| CONSOLE OPTIMA MCX BLUE | EU MDR | Eu Md Class 2a | On Market | 0 |
| CONSOLE OPTIMA MCX GREEN | EU MDR | Eu Md Class 2a | On Market | 0 |
| CONSOLE OPTIMA MCX ORANGE | EU MDR | Eu Md Class 2a | On Market | 0 |
| CONSOLE OPTIMA MCX PINK | EU MDR | Eu Md Class 2a | On Market | 0 |
| CONSOLE OPTIMA MCX WHITE | EU MDR | Eu Md Class 2a | On Market | 0 |
| Console Biopower | EU MDR | Eu Md Class 2a | On Market | 0 |
| Console Chiropro 3rd Gen. | EU MDR | Eu Md Class 2a | On Market | 0 |
| Console Chiropro PLUS 3rd Gen. | EU MDR | Eu Md Class 2a | On Market | 0 |
| Console Global Display | EU MDR | Eu Md Class 2a | On Market | 0 |
| Console MEG-ENGINE II | EU MDR | Eu Md Class 2a | On Market | 0 |