Authorized Representative
🇫🇷 France
Active
Bien-Air Europe Sàrl
SRN: FR-AR-000011942
·
Rue du 8 Mai 1945 19-21, 94110 Arcueil, France
Manufacturers
4
Devices
142
Certificates
2
PRRCs
1
Basic Information
- Address
- Rue du 8 Mai 1945 19-21, 94110 Arcueil, France
- [email protected]
- VAT Number
- TVA: FR 95 311 533 020
- Trade Register
- N° de gestion 2014B03428
Non-EU Manufacturers
| Name | Country | SRN |
|---|---|---|
| Mecaplast SA | 🇨🇭 Switzerland | CH-MF-000044618 |
| Bien-Air Surgery SA | 🇨🇭 Switzerland | CH-MF-000016376 |
| Bien-Air Dental SA | 🇨🇭 Switzerland | CH-MF-000014661 |
Manufacturers
Mecaplast SA
Manufacturer
🇨🇭 Switzerland
Bien-Air Dental SA
Manufacturer
🇨🇭 Switzerland·12 Basic UDI-DIs·134 Devices·5 Importers·TÜV SÜD Product Service GmbH
Bien-Air Surgery SA
Manufacturer
🇨🇭 Switzerland·13 Importers·SGS Belgium NV
Bien-Air Surgery SA
Manufacturer
🇨🇭 Switzerland·3 Basic UDI-DIs·8 Devices·15 Importers
Certificates
| Type | Number | Manufacturer | Notified Body | Status |
|---|---|---|---|---|
| MDD Annex II (excluding section 4) | G1 065560 0002 Rev. 01 | Bien-Air Dental SA | TÜV SÜD Product Service GmbH | Expired |
| MDR QMS | CH23/00001091 | Bien-Air Surgery SA | SGS Belgium NV | Issued |
Devices
SET iCHIROPRO CA 20:1 L WL
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·9 countries
SET iCHIROPRO SU + PM 1:2
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·20 countries
SET iCHIROPRO SURGERY
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·21 countries
SET iCHIROPRO + CA 20:1 L MS
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·21 countries
SET iCHIROPRO
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·21 countries
Console iChiropro Surgery
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·22 countries
Console iChiropro
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·17 countries
SET iChiropro+CA 20:1 L KM MS
Device
EU MDD
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·32 countries
SET OSSEOCARE PRO KM_102971
Device
EU MDD
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·32 countries
Air motor AQUILON 830 SR
Device
EU MDD
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·32 countries
MOT AQUILON 830 IR NC
Device
EU MDD
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·32 countries
Touchscreen portrait + SD
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·31 countries
Touchscreen paysage + SD
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·31 countries
IDUP Board
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·31 countries
Console iOptima INT MX2 MX-i
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·31 countries
Console iOptima INT 2xMX2
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·31 countries
Console iOptima INT 1xMX2
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·31 countries
TU Bora 2 LK
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·31 countries
TU Bora 2 LED
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·31 countries
Tur Tornado S LK
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·31 countries
Tur Tornado S LED
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·31 countries
Tur Tornado LK
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·31 countries
Tur Tornado LED
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·31 countries
Tur Boralina
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·31 countries
Tur Black Pearl ECO 4H
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·31 countries
Tur Black Pearl ECO 3H
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·31 countries
CA PRIMA 1:121
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·14 countries
CA PRIMA 1:1 L MS
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·14 countries
CA PRIMA 1:1 L
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·14 countries
CA PRIMA 1:1
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·14 countries
CA 1:1
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·31 countries
CA 1:2.5 L MS
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·31 countries
CA 1:2.5 L
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·31 countries
CA NOVA 1:5L MS
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·31 countries
CA NOVA 1:5L
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·31 countries
CA NOVA 1:1L MS
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·31 countries
CA NOVA 1:1L
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·31 countries
PM 1:2
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·31 countries
PM 1:1 Micro-Series
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·31 countries
PM 1:1 Ext Spray
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·31 countries
PM 1:1
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·31 countries
CA eLINE 1:5 L
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·31 countries
CA eLINE 1:1 L
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·31 countries
CA 20:1L Micro-Series
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·31 countries
CA 20:1 LKM Micro-Series
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·31 countries
CA 20:1 L Micro-Series
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·31 countries
CA 20:1 L KM Micro-Series
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·31 countries
CA 20:1 L KM
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·31 countries
CA 20:1 L
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·31 countries
CA 20:1
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·31 countries
CA 1:5 L Micro-Series
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·31 countries
CA 1:5 L
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·31 countries
CA 1:5
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·31 countries
CA 1:1 L Micro-Series
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·31 countries
CA 1:1 L
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·31 countries
CONSOLE OPTIMA MCX WHITE
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·31 countries
CONSOLE OPTIMA MCX PINK
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·31 countries
CONSOLE OPTIMA MCX ORANGE
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·31 countries
CONSOLE OPTIMA MCX GREEN
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·31 countries
CONSOLE OPTIMA MCX BLUE
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·31 countries
Set Chiropro+ 3rd CA 20:1 L WL
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·7 countries
Set Chiropro 3rd Gen CA 20:1 L WL
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·7 countries
Console Global Display
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·5 countries
SET GLOBAL DISPLAY
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·5 countries
SET BIOPOWER
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·11 countries
Console Biopower
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·12 countries
SET MEG-ENGINE II
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·31 countries
Console MEG-ENGINE II
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·31 countries
SET Chiropro+ 3rd Gen KM
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·31 countries
Console Chiropro PLUS 3rd Gen.
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·31 countries
SET Chiropro 3rd Gen.
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·31 countries
SET Chiropro 3rd Gen CA 20:1 L KM
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·31 countries
SET Chiropro 3rd Gen CA 20:1 L
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·31 countries
SET Chiropro+ 3rd Gen
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·31 countries
SET Chiropro+ 3rd Gen CA 1:2.5L
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·31 countries
SET Chiropro 3rd Gen KM
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·31 countries
SET Chiropro+ 3rd Gen CA 20:1 L KM
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·31 countries
SET Chiropro+ 3rd Gen CA 20:1 L
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·31 countries
Console Chiropro 3rd Gen.
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·31 countries
BOARD DMX3 CAN BOX
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·31 countries
Mot MX-i LED
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·31 countries
MOT MX-I LED 3RD GEN
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·31 countries
Mot MX2
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·31 countries
Mot MX-i
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·31 countries
Mot MCX LED
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·31 countries
Mot MCX
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·31 countries
Mot MC3 LK
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·31 countries
Mot MC3 IR
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·31 countries
Mot MC3 (LED)
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·31 countries
Mot MC2 IR
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·31 countries
Mot Isolite LK
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·31 countries
Mot Isolite (LED)
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·31 countries
HOSE MX2 400 GREY 20.2x40
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·31 countries
Hose MX2 400 Grey
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·31 countries
HOSE MCX Grey 400° Ø20.2x40
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·31 countries
HOSE MCX GREY 2.2m
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·31 countries
Hose MCX Grey
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·31 countries
HOSE ISOLITE/MC2 SWIVEL GREY
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·31 countries
HOSE MCX 400 GREY
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·31 countries
HOSE ISOLITE/MC2 COILED BLACK
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·31 countries
HOSE ISOLITE WATER ADJ GREY
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·31 countries
HOSE ISOLITE SWIVEL GREY
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·31 countries
HOSE LIGHT MOTOR
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·31 countries
LIGHT MOTOR
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·31 countries
CABLE I-SURGE LED
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·31 countries
I-SURGE LED
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·31 countries
HOSE ISOLITE/MC2 GREY
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·31 countries
HOSE B-MX2 GREY
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·31 countries
HOSE B-MCX GREY
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·31 countries
HOSE 4VR400 GREY
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·31 countries
HOSE 4VLM11 GREY
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·31 countries
HOSE 4VLM Ø11 grey_100130
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·31 countries
HOSE 4VLM GREY
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·31 countries
DMX3 CAN
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·31 countries
DMX3 CAN
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·31 countries
CABLE MX-I LED 3RD GEN
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·31 countries
CABLE MX-i LED
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·31 countries
CABLE MX LED 3M
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·31 countries
BOARD DMX3 MCX 100 RPM
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·31 countries
BOARD DMX3 M BtoW
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·31 countries
BOARD DMX3 M BtoB
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·31 countries
BOARD DMX3 M BtoB
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·31 countries
BOARD DMX3 M Bornier
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·31 countries
BOARD DMX3 M Bornier
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·31 countries
BOARD DMCX
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·31 countries
BOARD DMX3 FULL OPEN
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·31 countries
XPU MMOTOR CABLE
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·31 countries
XPU MMOTOR NO LIGHT
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·31 countries
XPU MMOTOR LIGHT
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Dental SA·On the market·31 countries
MAINT GREASER
Device
EU MDR
·
Eu Md Class 1
·Bien-Air Dental SA·On the market·31 countries
MAINT GREASER
Device
EU MDR
·
Eu Md Class 1
·Bien-Air Dental SA·On the market·31 countries
MAINT LUBRIMED CARTRIDGE
Device
EU MDR
·
Eu Md Class 1
·Bien-Air Dental SA·On the market·31 countries
MAINT AQUA CARE BOX OF 6 CANS
Device
EU MDR
·
Eu Md Class 1
·Bien-Air Dental SA·On the market·31 countries
MAINT LUBRIFLUID (BOX 6 CANS)
Device
EU MDR
·
Eu Md Class 1
·Bien-Air Dental SA·On the market·31 countries
PM2 Sterilization Tray 300025
Device
EU MDR
·
Eu Md Class 1
·Bien-Air Surgery SA·Not intended for eu market
PM2 Sterilization Tray Neuro
Device
EU MDR
·
Eu Md Class 1
·Bien-Air Surgery SA·On the market·7 countries
PM2 Sterilization Tray ENT
Device
EU MDR
·
Eu Md Class 1
·Bien-Air Surgery SA·On the market·10 countries
S120 Sterilization Tray
Device
EU MDR
·
Eu Md Class 1
·Bien-Air Surgery SA·On the market·10 countries
OSSEOSTAP Sterilization Tray
Device
EU MDR
·
Eu Md Class 1
·Bien-Air Surgery SA·On the market·16 countries
E-type Sterilization Tray
Device
EU MDR
·
Eu Md Class 1
·Bien-Air Surgery SA·On the market·12 countries
ORIGO Foot Pedal
Device
EU MDR
·
Eu Md Class 1
·Bien-Air Surgery SA·On the market·8 countries
ORIGO Control Unit
Device
EU MDR
·
Eu Md Class 2a
·Bien-Air Surgery SA·On the market·8 countries