BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Suspension System Arms: ACROBAT 3000; ONDASPACE; SPACEPORT; Central Axis; Hybrid Central Axis;

    Reg #: 3009028104 · FEI: 3009028104 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    16
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    ONDAL MEDICAL SYSTEMS OF AMERICA, INC.
    Registration Number
    3009028104
    FEI Number
    3009028104
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    540 Eastpark Ct Ste A
    City
    Sandston
    State
    VA
    ZIP
    23150
    Country
    US

    Owner / Operator

    Firm Name
    Ondal Medical Systems of America, Inc.
    Operator Number
    10042526
    Address
    540 Eastpark Court, Suite A
    City
    Sandston
    State
    VA
    Postal Code
    23150
    Country
    US
    Correspondent
    Terry T Ward

    Products

    Device Name Product Code
    Table, Operating-Room, Ac-Powered FQO

    Proprietary Names

    Suspension System Arms: ACROBAT 3000; ONDASPACE; SPACEPORT; Central Axis; Hybrid Central Axis; Suspension Spring Arms: VALiA,(L; MD; XRS; LCH) Monitor Carrier System: VALiA Display; Heavy Duty Arms: VALiA X,(EA1; EA2; Boom; EA1/MD; MD60; MD90; MD110; CT110-S; CT110; DT; V; DT; H) Suspension System Arms: VALiA,(S; S1; S1+; S2; S2+; S3; C1; C2; C1S1; C1S1+; C1S2; C2S1; C2S1+; C2S2; S/C; Triple Plate) Heavy Duty Pendant: MediHoist,(Friction; Power Rail) MRI Monitor Carrier: Vista,(VALiA+, 1-fold; MRI; VALiA+, 2-fold, MRI) Heavy Duty Arms: MediBoom,(Single; Dual; Friction; Air; AirPlus; Inverted; XL; XXL); MediLift (150; 210; 250; 180; XL) MRI Suspension System: VALiA,(C1, MRI; C2, MRI; C, EA2, MRI; S/C,CT110,MRI) Med. Supply Unit: Service Head M6(-200; -400; -600; -800; -1000; -Lifter; -Lifter-S); MediSpace; SpacePoint; Mon. Carrier Accessories: Vista,(handle,steel; handle adapter; handle steriliz.; handle dispos.; VESA 200 adapter; Box) MRI Spring Arms: VALiA,(MD23+; MRI; MD26+; MRI) Med. Supply Unit: Ceiling Unit M20 (w/MediBoom-H; w/MediLift-H; w/VALiA X-H; w/MediBoom-V; w/MediLift-V; w/VALiA X-V) Monitor Carrier: CEMOR,( 1; 2; 3; 4; 6; 8; LS; C4; C6; C8; C LS; X 2; X LS) VarioView, (1-fold; 2-fold; 26; 32) Suspension System Arms: ACROBAT 2000; ACROBAT SWING; ACROBAT 77; Monitor Carrier: Vista,(VALiA; VALiA+; OSP)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Complaint File Establishment per 21 CFR 820.198