BEUDAMED
    FDA Registration Active 🇲🇽 Mexico

    Flextronics Manufacturing Juarez S. DE R.L. DE C.V.

    Reg #: 3007344957 · FEI: 3007344957 · Expires 2026
    View on FDA
    Products
    32
    Proprietary Names
    48
    Establishment Types
    2
    Classifications
    32

    Registration Details

    Registration Name
    Flextronics Manufacturing Juarez S. DE R.L. DE C.V.
    Registration Number
    3007344957
    FEI Number
    3007344957
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Boulevard Independencia No. 4240, Col. Lote Bravo
    City
    Juarez Chihuahua
    Country
    MX

    Regulatory Submissions

    510(k) Number
    K852893

    Owner / Operator

    Firm Name
    Flextronics International USA, Inc.
    Operator Number
    9006592
    Address
    12455 Research Blvd
    City
    Austin
    State
    TX
    Postal Code
    78759
    Country
    US
    Correspondent
    Chad Ashton

    US Agent

    Business Name
    FLEXTRONICS INTERNATIONAL USA, INC.
    Contact Name
    Chad Ashton
    Address
    12455 Research Blvd
    City
    Austin
    State
    TX
    ZIP
    78759
    Country
    US
    Email
    [email protected]
    Phone
    901 8712423

    Products

    Device Name Product Code
    Applicator, Absorbent Tipped, Sterile KXG
    Needle, Hypodermic, Single Lumen FMI
    Container, Sharps MMK
    Cannula, Ophthalmic HMX
    Gauze / Sponge,Nonresorbable For External Use NAB
    Container, I.V. KPE
    Nebulizer (Direct Patient Interface) CAF
    Brush, Scrub, Operating-Room GEC
    Set, Administration, Intravascular FPA
    Drape, Patient, Ophthalmic HMT
    Stopcock, I.V. Set FMG
    Tray, Surgical, Instrument FSM
    Syringe, Piston FMF
    Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter QUG
    Generator, Oxygen, Portable CAW
    General Surgery Tray LRO
    Self-Fitting Air-Conduction Hearing Aid, Over The Counter QUH
    Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) HOY
    Self-Fitting Air-Conduction Hearing Aid, Prescription QDD
    Surgeon'S Gloves KGO
    Gown, Surgical FYA
    Knife, Ophthalmic HNN
    Unit, Phacofragmentation HQC
    Ventilator, Continuous, Facility Use CBK
    Continuous, Ventilator, Home Use NOU
    Needle, Suturing, Disposable GAB
    Pad, Eye HMP
    Drape, Surgical, Exempt PUI
    Instrument, Manual, Surgical, General Use MDM
    Needle, Aspiration And Injection, Disposable GAA
    Tubing, Noninvasive GAZ
    Tube, Aspirating, Flexible, Connecting BYY

    Proprietary Names

    DRESSING,TRANSPARENT 5 1/2 X 4, APPLICATOR,COTTON TIP,WOOD,3" B-D GUARDIAN CHEMOTHERAPY SHARPS COLLECTORS BD Recyleen Sharps Collectors CANNULA,VISCO INJ,30G, CANNULA,ANT CHAMBER,27G,8MM, CANNULA,HYDRODISS,27G,FLAT EN SPONGE,KERLIX,ROLL,4.5X147 SPONGE,TONSIL,LARGE,1" SPONGE,GAUZE,4PLY,4X4 SPONGE,NUGAUZE,4PLY,3X3 SPONGE,GAUZE,8PLY,2X2 SPONGE,LAP,12X12,PREWASHED SPONGE,KERLIX,6X6.75 DECANTER,VIAL Innospire Go Direct Patient Interface SPONGE,TONSIL,XLARGE, SPONGE,GAUZE,FLUFF,LARGE SET,EXTENSION,48",M:L/L,F:L/L DRAPE,OPH,INCISE,40X48,W/PCH COVER,BACKTABLE,44"X75",SMS,EM STOPCOCK, 1-WAY tray, surgical, instrument - TRAYS AND RACKS.; VARIOUS TYPES OF CASES 10 Tray, Sugical instrument, Matrixrib Compact, MiniModule, Vario Case, Vario Tray, Zip Fix SYRINGE,1CC,TB W/25GX5/8. Jabra Enhance Select 50R Millenium M10 Alcon Surgical Procedure Packs Enhance Plus SHIELD,EYE,PLST CLEAR,W/O GRTR GN Hearing B-D GUARDIAN POINT OF USE HORIZONTAL AND SIDE ENTRY SHARPS COLLECTORS Everflo - L4 OXYGEN CONCENTRATOR VACUTAINER BRAND NEEDLE DISPOSAL CONTAINER I-NEB TIM/General Purpose SYRINGE,1CC,TB W/26GX3/8 GLOVES,SURG,8,SENSICARE,PF GLOVES,SURG,6.5,SENSICARE,PF GOWN,AEROBLUE XLRG,NS GOWN,AEROBLUE LARGE,NS KNIFE,CLEARCUT,HP2,SLIT,2.8MM KNIFE,SATINCRESCENT,STRAIGHT KNIFE,15',ANG,STRT,SIDEPORT,SA KNIFE,SLIT,2.2MM,XSTAR,SAF,ANG B-D GUARDIAN NESTABLE SHARPS COLLECTORS I-Neb AAD Nebulizer w/Insight SW or Components ASSY,SHIP,CEN A .9 30BAL SensiCare Sterile Power-Free Polymer Coated Polyisoprene Surgical Glove, Coated with Aloe Trilogy EVO, O2, International, Trilogy EVO International, EV300 International w/OBM Gloves, Surg, 6.5, 7, 7.5, 8, 8.5. Protexis, PF, SY COUNTER,NEEDLE,80-160,FOAM/MAG, COUNTER,NEEDLE,30-60,DBL MAG, COUNTER,NEEDLE,30-60,DBL FOAM, COUNTER,NEEDLE,30-60,FOAM/MAG B-D GUARDIAN NESTABLE SHARPS COLLEC PAD,EYE,OVAL DRAPE,OPH,INCISE,40X50,W/PCH DRAPE,INCISE,48"X51",W/PCH GLOVES,SURG,6.5,PROTEXIS,PF GLOVES,SURG,6.5,SENSICARE,PF GLOVES,SURG,6.5,PROTEXIS,PF GLOVES,SURG,7,PROTEXIS,PF HOLDER,BLADE SCALPEL Needle, aspiration and injection, reusable BONE BIOPSY NEEDLE; CHIBA NEEDLE; PERCUCUT NEEDLES, N105, N110, N115, N710, N715, N810. N815 BD NEEDLE,25GX7/8, BD NEEDLE,20GX1-1/2 TUBING,SUCTION,1/4"X10',NON-CD B-D GUARDIAN ONE PIECE SHARPS COLLECTORS TUBING,SUCTION,3/16"X12'

    Establishment Types

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