BEUDAMED
    FDA Registration Active 🇺🇸 United States

    OPTEC USA, INC.

    Reg #: 1063727 · FEI: 3001779564 · Expires 2026
    View on FDA
    Products
    10
    Proprietary Names
    11
    Establishment Types
    2
    Classifications
    10

    Registration Details

    Registration Name
    OPTEC USA, INC.
    Registration Number
    1063727
    FEI Number
    3001779564
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    975 PROGRESS CIRCLE
    City
    LAWRENCEVILLE
    State
    GA
    ZIP
    30043
    Country
    US

    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

    Products

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

    Proprietary Names

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

    Establishment Types

    Manufacture Medical Device Repack or Relabel Medical Device