BEUDAMED
    FDA Registration Active 🇩🇴 Dominican Republic

    DEROYAL INTERCONTINENTAL, S.R.L.

    Reg #: 3004605321 · FEI: 3004605321 · Expires 2026
    View on FDA
    Products
    95
    Proprietary Names
    99
    Establishment Types
    3
    Classifications
    95

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    Registration Details

    Registration Name
    DEROYAL INTERCONTINENTAL, S.R.L.
    Registration Number
    3004605321
    FEI Number
    3004605321
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    KM 7, Autopista Joaquin Balaguer, Pisano Free Zone, Building 49
    City
    SANTIAGO
    Country
    DO

    Regulatory Submissions

    510(k) Number
    K980987

    Owner / Operator

    Firm Name
    DEROYAL INDUSTRIES, INC.
    Operator Number
    1044833
    Address
    200 DEBUSK LN., --
    City
    Powell
    State
    TN
    Postal Code
    37849
    Country
    US
    Correspondent
    Elizabeth Reed

    US Agent

    Business Name
    DeRoyal Industries, Inc.
    Contact Name
    Elizabeth Reed
    Address
    200 DEBUSK LN
    City
    POWELL
    State
    TN
    ZIP
    37849
    Country
    US
    Email
    [email protected]
    Phone
    865 3621256

    Products

    Device Name Product Code
    Orthosis, Limb Brace IQI
    Basin, Emesis FNY
    Laparoscopy Kit FDE
    Blade, Scalpel GES
    Container, Specimen, Sterile FMH
    Syringe, Piston FMF
    Instrument, Surgical, Disposable KDC
    Kit, Surgical Instrument, Disposable KDD
    Tubing, Pressure And Accessories BYX
    Negative Pressure Wound Therapy Powered Suction Pump OMP
    Instrument, Manual, Surgical, General Use MDM
    Blood Pressure Cuff DXQ
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Catheter, Irrigation GBX
    Dispenser, Liquid Medication KYX
    Container, Empty, For Collection & Processing Of Blood & Blood Components KSR
    Forceps, General & Plastic Surgery GEN
    Accessories, Traction ILZ
    Injector And Syringe, Angiographic DXT
    Instruments, Surgical, Cardiovascular DWS
    Scissors, Medical, Disposable JOK
    Orthosis, Lumbo-Sacral IPY
    Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass DTL
    Pack, Hot Or Cold, Disposable IMD
    Protector, Skin Pressure FMP
    Restraint, Protective FMQ
    Set, Administration, Intravascular FPA
    Anti Fog Solution And Accessories, Endoscopy OCT
    Support, Arm IOY
    Angiography/Angioplasty Kit OEQ
    Dressing, Wound, Occlusive NAD
    Orthosis, Cervical IQK
    Gauze/Sponge, Internal EFQ
    Pack, Hot Or Cold, Reusable IME
    Dissector, Surgical, General & Plastic Surgery GDI
    Tourniquet Kit OJS
    Marker, Skin FZZ
    Bandage, Elastic FQM
    Shoe, Cast IPG
    Needle, Hypodermic, Single Lumen FMI
    Transducer, Blood-Pressure, Extravascular DRS
    Instrument, Cranioplasty Material Forming HBX
    Skin Prep Tray OJU
    Container, I.V. KPE
    Dressing Change Tray OXQ
    Device, Occlusion, Umbilical FOD
    Scissors, General, Surgical LRW
    Catheter, Urological KOD
    Catheter, Intravascular, Diagnostic DQO
    Probe HXB
    Light, Surgical, Accessories FTA
    Handle, Scalpel GDZ
    Tubing/Tubing With Filter, Insufflation, Laparoscopic NKC
    Splint, Hand, And Components ILH
    Slides, Microscope KEW
    Snare, Surgical GAE
    Wire, Guide, Catheter DQX
    Splint, Extremity, Inflatable, External FZF
    Connector, Catheter GCD
    Drape, Surgical, Exempt PUI
    Joint, Knee, External Brace ITQ
    Accessory, Surgical Apparel LYU
    Cotton, Roll EFN
    Monitor, Bed Patient KMI
    Gauze/Sponge, Internal, X-Ray Detectable GDY
    Pack, Hot Or Cold, Water Circulating ILO
    Hemostat HRQ
    Insufflator, Laparoscopic HIF
    Pneumoperitoneum Needle FHO
    Cover, Limb IPM
    Sponge, Ophthalmic HOZ
    Applicator, Absorbent Tipped, Sterile KXG
    Bottle, Collection, Vacuum KDQ
    Tape And Bandage, Adhesive KGX
    Fiber, Medical, Absorbent FRL
    Suture Removal Kit MCZ
    Accessory Equipment, Cardiopulmonary Bypass KRI
    Gauze / Sponge,Nonresorbable For External Use NAB
    Holder, Needle, Gastroenterologic FHQ
    Sling, Arm ILI
    Clamp, Surgical, General & Plastic Surgery GDJ
    Tourniquet, Nonpneumatic GAX
    Anesthesia Conduction Kit CAZ
    Needle, Conduction, Anesthetic (W/Wo Introducer) BSP
    Dressing, Compression MHW
    Halter, Head, Traction HSS
    Joint, Ankle, External Brace ITW
    Bandage, Cast ITG
    Laparoscope, General & Plastic Surgery GCJ
    Container, Specimen, Non-Sterile NNI
    General Surgery Tray LRO
    Applicator, Absorbent Tipped, Non-Sterile KXF
    Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) HOY
    Binder, Abdominal FSD
    Accessories, Catheter KGZ

    Proprietary Names

    Orthosis, Limb Brace - DeRoyal Basin, Emesis - DeRoyal Laparoscopy Kit - DeRoyal Blade, Scalpel - DeRoyal Container, Specimen, Sterile - DeRoyal Syringe, Piston - DeRoyal Instrument, Surgical, Disposable - DeRoyal Kit, Surgical Instrument, Disposable - DeRoyal Tubing, Pressure and Accessories - DeRoyal Negative Pressure Wound Therapy Powered Suction Pump - DeRoyal Instrument, Manual, Surgical, General Use - DeRoyal Blood Pressure Cuff - DeRoyal Electrosurgical, Cutting & Coagulation & Accessories - DeRoyal Catheter, Irrigation - DeRoyal Dispenser, Liquid Medication - DeRoyal Container, Empty, for Collection & Processing of Blood & Blood Components - DeRoyal Forceps, General & Plastic Surgery - DeRoyal BLOOD PRESSURE CUFF - DeRoyal Accessories, Traction - DeRoyal Injector and Syringe, Angiographic - DeRoyal Instruments, Surgical, Cardiovascular - DeRoyal Scissors, Medical, Disposable - DeRoyal Orthosis, Lumbo-Sacral - DeRoyal Oxygenator, Cardiopulmonary Bypass - DeRoyal DEROYAL THERMO-COLD S Pack, Hot and Cold, Disposable - DeRoyal Protector, Skin Pressure - DeRoyal Restraint, Protective - DeRoyal Set, Administration, Intravascular - DeRoyal Anti Fog Solution and Accessories, Endoscopy - DeRoyal Support, Arm - DeRoyal Angiography/Angioplasty Kit - DeRoyal Dressing, Wound, Occlusive - DeRoyal Orthosis, Cervical - DeRoyal Gauze/Sponge, Internal - DeRoyal Pack, Hot or Cold, Reuseable - DeRoyal Dissector, Surgical, General & Plastic Surgery - DeRoyal Tourniquet Kit - DeRoyal Marker, Skin - DeRoyal Bandage, Elastic - DeRoyal Shoe, Cast - DeRoyal Needle, Hypodermic, Single Lumen - DeRoyal Transducer, Blood-Pressure, Extravascular - DeRoyal Instrument, Cranioplasty Material Forming - DeRoyal Skin Prep Tray (Kit)- DeRoyal Container, I. V. - DeRoyal Dressing Change Tray - DeRoyal Device, Occlusion, Umbilical - DeRoyal Scissors, General, Surgical - DeRoyal Catheter, Urological - DeRoyal Catheter, Intravascular, Diagnostic - DeRoyal Probe - DeRoyal Light, Surgical, Accessories - DeRoyal Handle, Scalpel - DeRoyal Tubing/Tubing with Filter, Insufflation, Laparoscopic - DeRoyal Splint, Hand, and Components - DeRoyal WRIST MICROSCOPE SLIDES - DeRoyal Set, administration, intravascular - DeRoyal Snare, Surgical - DeRoyal Wire, Guide, Catheter - DeRoyal Splint, Extremity, Inflatable, External - DeRoyal Connector, Catheter - DeRoyal Drape, Surgical, Exempt - DeRoyal Joint, Knee, External Brace - DeRoyal Accessory, Surgical Apparel - DeRoyal Cotton, Roll - DeRoyal Monitor, Bed Patient - DeRoyal Gauze/Sponge, Internal, X-Ray Detectable - DeRoyal Pack, Hot or Cold, Water Circulating - DeRoyal Hemostat - DeRoyal Pneumoperitoneum Needle - DeRoyal Cover, Limb - DeRoyal Sponge, Ophthalmic - DeRoyal Applicator, Absorbent Tipped, Sterile - DeRoyal Bottle, Collection, Vacuum - DeRoyal Tape and Bandage, Adhesive - DeRoyal Fiber, Medical, Absorbent - DeRoyal Suture Removal Kit - DeRoyal Accessory Equipment, Cardiopulmonary Bypass - DeRoyal Gauze/Sponge, Nonresorbable for External Use - DeRoyal Holder, Needle, Gastroenterologic - DeRoyal Sling, Arm - DeRoyal Clamp, Surgical, General & Plastic Surgery - DeRoyal Tourniquet, Nonpneumatic - DeRoyal Anesthesia Conduction Kit - Needle, Conduction, Anesthetic (w/wo Introducer) - DeRoyal Dressing, Compression - DeRoyal Halter, Head, Traction - DeRoyal Joint, Ankle, External Brace - DeRoyal Bandage, Cast - DeRoyal Laparoscope General and Plastic Surgery - DeRoyal Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass - DeRoyal Container, Specimen, Non-Sterile - DeRoyal General Surgery Tray (Kit) - DeRoyal General Surgery Tray - DeRoyal Applicator, Absorbent Tipped, Non-Sterile - DeRoyal Shield, Eye, Ophthalmic (including sunlamp protective eyewear and post-mydriatic eyewear) - DeRoyal Binder, Abdominal - DeRoyal Accessories, Catheter - DeRoyal

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Repack or Relabel Medical Device Export Device to the United States But Perform No Other Operation on Device