BEUDAMED
    FDA Registration Active 🇺🇸 United States

    DARCO INTERNATIONAL, INC.

    Reg #: 1122845 · FEI: 1000123428 · Expires 2026
    View on FDA
    Products
    15
    Proprietary Names
    76
    Establishment Types
    4
    Classifications
    15

    Registration Details

    Registration Name
    DARCO INTERNATIONAL, INC.
    Registration Number
    1122845
    FEI Number
    1000123428
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    810 Memorial Blvd W
    City
    HUNTINGTON
    State
    WV
    ZIP
    25701
    Country
    US

    Owner / Operator

    Firm Name
    DARCO INTERNATIONAL, INC.
    Operator Number
    9001626
    Address
    810 MEMORIAL BLVD., --
    City
    Huntington
    State
    WV
    Postal Code
    25701
    Country
    US

    Products

    Device Name Product Code
    Splint, Extremity, Non-Inflatable, External, Non-Sterile NOC
    Orthosis, Lumbo-Sacral IPY
    Joint, Ankle, External Brace ITW
    Splint, Extremity, Inflatable, External FZF
    Protector, Skin Pressure FMP
    Shoe, Cast IPG
    Tape And Bandage, Adhesive KGX
    Binder, Abdominal FSD
    Splint, Hand, And Components ILH
    Orthosis, Corrective Shoe KNP
    Sling, Arm ILI
    Stocking, Medical Support (For General Medical Purposes) FQL
    Splint, Clavicle IQJ
    Esthesiometer GXB
    Joint, Knee, External Brace ITQ

    Proprietary Names

    BODY ARMOR WALKER BODY ARMOR PRO TERM ACTIVE ANKLE DORSAL NIGHT SPLINT BODY ARMOR WALKER II BODY ARMOR NIGHT SPLINT FX PRO ANTERIOR CARBON FIBER AFO COMPONENT KIT ANT AFO TOE ALIGNMENT SPLINT BODY ARMOR STIRRUP WALKER GREAT TOE SPLINT Body Armor PFA Walker ANT AFO TABS SACRO LUMBAR SUPPORT DARCO SACRO LUMBAR SUPPORT ANKLE EXTERNAL BRACE DARCO ANKLE BRACE DARCOGEL ANKLE BRACE BODY ARMOR SPORT BODY ARMOR STIRRUP WEB ANKLE BRACE BODY ARMOR VARIO Pneumatic Night Splint Body Armor Stirrup Walker Pneumatic Air Traveler Walker Body Armor PFA Walker Liner WALKER LINER MULTI PHASE PADS PEG ASSIST ACTIMOVE LINER BODY ARMOR HEEL RELIEVER SPENCO BOOT LINER BODY ARMOR TOE GUARD MEDICAL SURGICAL SHOE Body Armor Cast Shoe Vinyl Closed Toe Cast Boot Slimline Cast Boot Polycast Cast Boot Low Profile Cast Shoe Canvas/Open Toe Cast Shoe Standard Open Toe Cast Boot Body Armor Tape Darco Abdominal Binder BUNGEE WRIST DARCO WRIST BRACE AllRound Shoe Gentle Step Wound Care Shoe Duo Shoe Heelwedge Pogo Pulsus Ultra Off Loading Shoe Strapless Shoe All Purpose Boot Softie Shoe Medical Surgical Shoe Orthowedge Original Medical Surgical Shoe Duo Pro SLING AND SWATHE DARCO ARM SLING SHOULDER IMMOBILIZER EXTREMIT-EASE COMPRESSION GARMENT EXTREMIT-EASE GARMENT LINER FS6 DCS Plantar Fasciitis Sleeve DARCO SHOULDER IMMOBILIZER DARCO CLAVICAL SPLINT UNIVERSAL TEMP TOUCH FOOT FILAMENT MONOTEMP Monofilament Tester Foot Tester DARCO KNEE BRACE

    Establishment Types

    Repack or Relabel Medical Device Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device