BEUDAMED
    FDA Registration Active 🇩🇴 Dominican Republic

    OPTEC USA, INC

    Reg #: 3011528799 · FEI: 3011528799 · Expires 2026
    View on FDA
    Products
    10
    Proprietary Names
    11
    Establishment Types
    2
    Classifications
    10

    Registration Details

    Registration Name
    OPTEC USA, INC
    Registration Number
    3011528799
    FEI Number
    3011528799
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    SOLAR 3, MANZANA 2-B, ZONA FRANCA INDUSTRIAL SAN PEDRO DE MACORIS
    City
    SAN PEDRO DE MACORIS
    Country
    DO

    Owner / Operator

    Firm Name
    OPTEC USA, INC.
    Operator Number
    9033352
    Address
    975 PROGRESS CIRCLE, --
    City
    Lawrenceville
    State
    GA
    Postal Code
    30043
    Country
    US
    Correspondent
    Daniel - Suarez

    US Agent

    Business Name
    Optec USA, Inc.
    Contact Name
    NEHEMIAH J. SUAREZ
    Address
    975 Progress Circle
    City
    Lawrenceville
    State
    GA
    ZIP
    30043
    Country
    US
    Email
    [email protected]
    Phone
    770 5137380

    Products

    Device Name Product Code
    Joint, Hip, External Brace ITS
    Orthosis, Lumbo-Sacral IPY
    Joint, Knee, External Brace ITQ
    Orthosis, Lumbar IQE
    Orthosis, Thoracic IPT
    Insoles, Medical KYS
    Joint, Shoulder, External Limb Component IQQ
    Orthosis, Cervical-Thoracic, Rigid IQF
    Orthosis, Cervical IQK
    Orthosis, Truncal/Orthosis, Limb MRI

    Proprietary Names

    JOINT, HIP, EXTERNAL BRACE ORTHOSIS LUMBO-SACRAL EDGE, EVOTEC, LUMBITEC, OASIS SOFT, PRIMO, SALO, STEALTH, STOCK MINERVA ATTACHMENTS, STOCK STERNAL PAD KIT JOINT, KNEE, EXTERNAL BRACE ORTHOSIS, LUMBAR ORTHOSIS, THORACIC INSOLES, MEDICAL JOINT, SHOULDER, EXTERNAL LIMB COMPONENT ORTHOSIS, CERVICAL-THORACIC, RIGID Orthosis, cervical OPTEC LIMB

    Establishment Types

    Manufacture Medical Device Repack or Relabel Medical Device