BEUDAMED
    FDA Registration Active 🇵🇹 Portugal

    SET CHIROPRO L US PM HP 1:2

    Reg #: 3013576763 · FEI: 3013576763 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    66
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    BIEN-AIR PORTUGAL, UNIPESSOAL LDA
    Registration Number
    3013576763
    FEI Number
    3013576763
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Rua Ponte da Pedra, N 240, Centro Empresarial Aaa
    City
    Maia Porto
    Country
    PT

    Regulatory Submissions

    510(k) Number
    K092214

    Owner / Operator

    Firm Name
    BIEN-AIR DENTAL SA
    Operator Number
    9034059
    Address
    Langgasse 60, --
    City
    BIENNE
    State
    Bern
    Postal Code
    2504
    Country
    CH
    Correspondent
    Carine - Beriet

    US Agent

    Business Name
    BIEN AIR USA, INC.
    Contact Name
    ARTHUR MATEEN
    Address
    5 CORPORATE PARK, SUITE 160
    City
    Irvine
    State
    CA
    ZIP
    92606
    Country
    US
    Email
    [email protected]
    Phone
    949 4776050

    Products

    Device Name Product Code
    Controller, Foot, Handpiece And Cord EBW

    Proprietary Names

    SET CHIROPRO L US PM HP 1:2 CONSOLE CHIROPRO PLUS 3RD GEN SET CHIROPRO L SET CHIROPRO L US SET CHIROPRO L PREMIUM SET CHIROPRO L PREMIUM CA 20:1 L SET OSSEOCARE US CONSOLE CHIROPRO CONSOLE CHIROPRO 3RD GEN CONSOLE CHIROPRO L PREMIUM US CONSOLE CHIROPRO L PREMIUM SET iCHIROPRO KM SET iCHIROPRO SURGERY US PM HP 1:2 MOT MXi-LED SET CHIROPRO+ CA 20:1 L CONSOLE OSSEOCARE US SET iCHIROPRO SURGERY US CONSOLE CHIROPRO L US CA 20:1 L SET CHIROPRO L + CA 20:1 L SET CHIROPRO CA 20:1 L SET iCHIROPRO + CA 20:1 L MS SET iCHIROPRO CA 20:1 L MS KM SET OSSEOCARE CA 20:1 L MS NB CA 20:1 l MICRO SERIES SET CHIROPRO SET CHIROPRO L US CA 20:1 L SET OSSEOCARE US CA 20:1 L MS SET CHIROPRO L CA 20:1 SET PROIMPLANT SET CHIROPRO + CA 20:1 CA 20:1 SET CHIROPRO 3RD GEN CA 20:1L AQUACARE CABLE MX-i LED 3RD GEN FOOTCTRL CHIROPRO980 MOT MX-i LED 3RD GEN SET CHIROPRO 3RD GEN Chiropro 980 4 Buttons Foot Control CABLE MX LED 3M CONSOLE PROIMPLANT SET CHIROPRO 3RD GEN KM CONSOLE PROIMPLANT 3RD GEN SET OMS SET PROIMPLANT 3RD GEN CA 20:1 L CONSOLE OMS FOOTCTRL SET CHIROPRO 3RD GEN KM CA SET PROIMPLANT 3RD GEN CA 20:1 CONSOLE iCHIROPRO MOT MX-LED SET OSSEOCARE PRO CABLE MX-LED CONSOLE CHIROPRO L MOT MX-i LED SET iCHIROPRO CONSOLE OSSEOCARE PRO CA 20:1 L MICRO-SERIES SET CHIROPRO L US PREMIUM SET iCHIROPRO SURGERY CONSOLE OSSEOCARE CONSOLE iCHIROPRO SURGERY SET OSSEOCARE CABLE MX-i LED SET CHIROPRO+ 3RD GEN CA 20:1 L MOT MX-i

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)