BEUDAMED
    FDA Registration Active 🇲🇽 Mexico

    TRI-STATE DE MEXICO, S. DE R.L. DE C.V.

    Reg #: 3004519921 · FEI: 3005846326 · Expires 2026
    View on FDA
    Products
    136
    Proprietary Names
    43
    Establishment Types
    3
    Classifications
    136

    Registration Details

    Registration Name
    TRI-STATE DE MEXICO, S. DE R.L. DE C.V.
    Registration Number
    3004519921
    FEI Number
    3005846326
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Calzada Presidente Venustiano Carranza #301, DESARROLLO INDUSTRIAL COLORADO
    City
    MEXICALI Baja California
    Country
    MX

    Regulatory Submissions

    510(k) Number
    K113565

    Owner / Operator

    Firm Name
    Medline Industries, LP
    Operator Number
    1824619
    Address
    Three Lakes Drive, --
    City
    Northfield
    State
    IL
    Postal Code
    60093
    Country
    US
    Correspondent
    Stephanie Augsburg

    US Agent

    Business Name
    Centurion Medical Products, LP
    Contact Name
    KAREN KOWALCZYK KOWALCZYK
    Address
    100 Centurion Way
    City
    Williamston
    State
    MI
    ZIP
    48895
    Country
    US
    Email
    [email protected]
    Phone
    517 5465400

    Products

    Device Name Product Code
    Angiography/Angioplasty Kit OEQ
    Bandage, Cast ITG
    Instrument, Manual, Surgical, General Use MDM
    Retractor, Fiberoptic FDG
    Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days FOZ
    Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass DTL
    Syringe, Piston FMF
    Decontamination Kit MAC
    Electrocautery, Gynecologic (And Accessories) HGI
    Marker, Skin FZZ
    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief LGW
    Stimulator, Spinal-Cord, Totally Implanted For Relief Of Pain Due To Diabetic Neuropathy QRB
    Toothbrush, Manual EFW
    Fiber, Medical, Absorbent FRL
    Loop, Wire JYQ
    Introducer, Catheter DYB
    Central Venous Catheter Tray OFF
    Bone Marrow Biopsy Tray PXO
    Endoscopic Irrigation/Suction System OCX
    Scissors, Medical, Disposable JOK
    Forceps HTD
    General Surgery Tray LRO
    Tape, Measuring, Rulers And Calipers FTY
    Container, Specimen, Non-Sterile NNI
    Cardiac Catheterization Kit OES
    Speculum, Rectal FFQ
    Set, Administration, Intravascular FPA
    Nebulizer, Medicinal, Non-Ventilatory (Atomizer) CCQ
    Stethoscope, Manual LDE
    Labor And Delivery Kit MLS
    Forceps, Tube Introduction BWB
    Handle, Scalpel GDZ
    Hook, Gastro-Urology FHB
    Non-Surgical Gown OEA
    Instrument, Manual, General Obstetric-Gynecologic KOH
    Hook, Surgical, General & Plastic Surgery GDG
    Tracheobronchial Suction Catheter Kit OFR
    Container, Liquid Medication, Graduated KYW
    Laceration Tray PKD
    System, X-Ray, Angiographic IZI
    Brush, Cleaning, Tracheal Tube EPE
    Gauze/Sponge, Internal, X-Ray Detectable GDY
    Dilator, Cervical, Fixed Size HDQ
    Accessories, Catheter KGZ
    Bedding, Disposable, Medical KME
    Urine Collection Kit (Excludes Hiv Testing) OIE
    Catheters, Suction, Tracheobronchial BSY
    Tubing, Fluid Delivery FPK
    Liver Biopsy Kit PYA
    Computer, Diagnostic, Pre-Programmed, Single-Function DXG
    Transducer, Blood-Pressure, Extravascular DRS
    Bur, Surgical, General & Plastic Surgery GFF
    Tracheotomy Care Kit NXA
    Tape And Bandage, Adhesive KGX
    Holder, Needle, Gastroenterologic FHQ
    Restraint, Protective FMQ
    Cement, Bone, Vertebroplasty NDN
    Catheter Introducer Kit OFD
    Razor, Surgical LWK
    Neurosurgical Nerve Locator PDQ
    Urinary Drainage Collection Kit, For Indwelling Catheter FCN
    Tray, Start/Stop (Including Contents), Dialysis FKG
    Pad, Eye HMP
    Tray, Surgical, Instrument FSM
    Ear, Nose, And Throat Surgical Tray OGR
    Container, Specimen, Sterile FMH
    Dress, Surgical FYE
    Tubing, Noninvasive GAZ
    Dental Hygiene Kit NXZ
    Support, Patient Position CCX
    Protector, Skin Pressure FMP
    Speculum, Ent EPY
    General Purpose Dental Tray OFX
    Speculum, Vaginal, Nonmetal HIB
    Retention Device, Suture KGS
    I.V. Start Kit LRS
    Applicator, Vaginal HGD
    Applicator, Absorbent Tipped, Sterile KXG
    Gauze / Sponge,Nonresorbable For External Use NAB
    Retractor GAD
    Accessory, Surgical Apparel LYU
    Curette HTF
    Clamp, Circumcision HFX
    Wire, Guide, Catheter DQX
    Kit, Surgical Instrument, Disposable KDD
    Clamp, Umbilical HFW
    Ear Irrigation Kit OGQ
    Speculum, Vaginal, Metal HDF
    Tracheostomy And Nasal Suctioning Kit LRQ
    Basin, Emesis FNY
    Needle, Suturing, Disposable GAB
    Tube, Aspirating, Flexible, Connecting BYY
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Catheter And Tip, Suction JOL
    Clamp HXD
    Tourniquet, Nonpneumatic GAX
    Tray, Surgical LRP
    Mirror, Ent KAI
    Device, Intravascular Catheter Securement KMK
    Wound Dressing Kit MCY
    Sound, Uterine HHM
    Label Or Tag, Sterile LYV
    Drape, Surgical, Exempt PUI
    Breast Biopsy / Localization Tray PXP
    Ct Biopsy Tray OFG
    General Purpose Instrument Tray PXV
    Hemostat HRQ
    Arterial Blood Sampling Kit CBT
    Tube, Ear Suction JZF
    Suture Removal Kit MCZ
    Forceps, General & Plastic Surgery GEN
    Cardiovascular Procedure Kit OEZ
    Guide, Needle, Surgical GDF
    First Aid Kit With Drug LRR
    Drape, Surgical, Antimicrobial KKX
    System, Irrigation, Urological LJH
    Arthroscope HRX
    Pad, Alcohol, Device Disinfectant LKB
    Blood And Urine Collection Kit (Excludes Hiv Testing) OIB
    Device, Occlusion, Umbilical FOD
    Evacuator, Oral Cavity EHZ
    Scissors, General, Surgical LRW
    Syringe, Irrigating (Non Dental) KYZ
    Holder, Ureteral Catheter EYJ
    Dressing Change Tray OXQ
    Instrument, Surgical, Disposable KDC
    Lumbar Puncture Tray (Adult & Pediatric) PWY
    Circumcision Tray OHG
    Pelvic Exam Kit MLT
    Catheter, Intravascular, Diagnostic DQO
    Lens, Contact, Polymethylmethacrylate, Diagnostic HJK
    Scissors, Orthopedic, Surgical HRR
    System, Urine Drainage, Closed, For Non-Indwelling Catheter, Non-Sterile NNZ
    Skin Prep Tray OJU
    Bandage, Elastic FQM
    Plastic Surgery And Accessories Kit FTN

    Proprietary Names

    Retractor Flush Connector Centurion Medline Master Restore, Itrel®, Synergy®, Intellis™ and Vanta™ Spinal Cord Stimulation Systems and Pisces™, Specify®, and Vectri Medline Branded Kits Centurion Branded Kits FORCEPS Medline General Surgery Tray Tracheobronchial suction catheter kit Laceration tray NAMIC CONTRAST MANAGEMENT SYSTEM; NAMIC CONTRAST CONTROLLER; NAMIC SQUEEZE CONTRAST CONTROLLER Medline Trach Brush Centurion Standard Extension Sets SorbaView SorbaView OTC SiteGuard VersaDerm SorbaView SHEILD HOLDER, NEEDLE, GASTROENTEROLOGIC cement, bone, vertebroplasty PHANTOM XL INSULATED DILATORS Medline Cardiovascular Procedure Kits Centurion Kits VARIOUS SIZES AND STYLE NEURO SUCTION TUBING / STERILE Medline Integrated Arterial Catheter Centurion CirClamp WINGGUARD SORBAVIEW SHIELD HUBGUARD SECUREVIEW NAMIC CLOSED FLUID SYSTEMS; NAMIC CONTRAST REMOVAL VALVE; NAMIC FILLING STATION; NAMIC FILLING STATION PLUS; NAMIC FLUID General purpose instrument tray Introducer Needle Srugical Drape Rectal Irrigation Kit Aplicare Alcohol Swabstick; Singles, Triples Occlusion, Umbilical Kits NAMIC Extension Sets Lens SCISSORS, ORTHOPEDIC, SURGICAL Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass

    Establishment Types

    Repack or Relabel Medical Device Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)