BEUDAMED
    FDA Registration Active 🇹🇼 Taiwan

    MICROWARE PRECISION CO., LTD.

    Reg #: 3007738812 · FEI: 3007738812 · Expires 2026
    View on FDA
    Products
    24
    Proprietary Names
    99
    Establishment Types
    2
    Classifications
    24

    Registration Details

    Registration Name
    MICROWARE PRECISION CO., LTD.
    Registration Number
    3007738812
    FEI Number
    3007738812
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    No. 12, Keyuan 2nd Rd., Situn District,
    City
    Taichung
    Country
    TW

    Regulatory Submissions

    510(k) Number
    K111008

    Owner / Operator

    Firm Name
    Microware Precision Co., Ltd.
    Operator Number
    10028733
    Address
    No. 12, Keyuan 2nd Rd., Situn District,
    City
    Taichung
    State
    TW-TXG
    Postal Code
    407736
    Country
    TW
    Correspondent
    Harrison Du

    Products

    Device Name Product Code
    Implant, Endosseous, Orthodontic OAT
    Plate, Fixation, Bone HRS
    Screw, Fixation, Bone HWC
    Washer, Bolt, Nut, Non-Spinal, Metallic NDG
    Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component KTT
    Guide, Surgical, Instrument FZX
    Cover, Burr Hole GXR
    Plate, Cranioplasty, Preformed, Alterable GWO
    Fastener, Plate, Cranioplasty HBW
    Plate, Bone JEY
    Screw, Fixation, Intraosseous DZL
    Plate, Cranioplasty, Preformed, Non-Alterable GXN
    Bur, Surgical, General & Plastic Surgery GFF
    Thoracolumbosacral Pedicle Screw System NKB
    Orthosis, Spinal Pedicle Fixation MNI
    Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis OSH
    Orthosis, Spondylolisthesis Spinal Fixation MNH
    Bit, Drill HTW
    Washer, Bolt Nut HTN
    Orthopedic Manual Surgical Instrument LXH
    Template HWT
    Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite LXT
    Accessories, Implant, Dental, Endosseous NDP
    Retainer, Screw Expansion, Orthodontic DYJ

    Proprietary Names

    Orthodontic Ortholock Screw Microware Bone Plates and Bone Screws Drill guide, various types of drill guides BIOMET MICROFIXATION NEURO PLATING SYSTEM BIO-RAY A-1 Anchor Screw System Tandry Compression Screw System Tandry CMF Plate System SPIN DOWN RAPIDFLAP BUR, SURGICAL, GENERAL & PLASTIC SURGERY Tandry Q-Locking Plate System 3.2mm Cannulated Drill Bit, for 4.5mm Cannulated Screw 0.7mm Guide Wire 1.6mm Guide Wire, for 4.5mm cannulated Screw 0.8mm Guide wire, for 2.4mm Cannulated Screw 1.7mm Cannulated Drill Bit, for 2.4mm Cannulated Screw Drill Bit, 5/2.9mm, Cannulated, 7.3mm Cannulated Screw Guide Wire, 2.5mm dia., with threaded tip, length 230mm Guide Wire, 2.8mm dia., with spade point, length 300mm Drill Bit, 2.7/1.35mm, Cannulated Guide Wire. 1.25mm, with Thread Tip, Length 150mm various types of drill OIC VARIABLE ANGLE SMALL FRAGMENT LOCKING PLATE SYSTEM Tandry Locking Plate System FlexFix Syndesmosis Repair Kit Screwdriver Shaft T8, Cannulated, for Cannulated Screw 2.4mm Screwdriver Shaft, Hexagonal, Cannulated Screw 6.5/7.3mm Countersink, Cannulated, for Cannulated Screw 2.4mm Measuring Device, for Cannulated Screw 2.4mm Double Drill Sleeve 1.7/0.8mm, for Cannulated Screw 2.4mm 2.4mm Cannulated Screws and Instruments Case Screw Forceps, for Cannulated Screw 2.4mm 7.3 CANNULATED SCREW AND INSTRUMENT SET Screwdriver Shaft, Hexagonal, 7.3mm Cannulated Screw Screwdriver, Hexagonal, 7.3mm Cannulated Screw Tap, Cannulated, 7.3mm Cannulated Screw Protection Sleeve 12/8.5mm, 7.3mm Cannulated Screw 135 Degree Angle Guide Impactor Tip Small T-Handle Screw Caddy, Cannulated Screw 7.3mm, Fully Threaded Screw Caddy, Cannulated Screw 7.3mm, Thread Length 32mm Drill Sleeve, 8.5/2.8mm, 7.3mm Cannulated Screw Screw Forceps, Self-rataining Protection Sleeve, 15.5/13mm, 7.3mm Cannulated Screw 145 Degree Angle Guide Triple Reamer Drill Bit Shaft 3.5mm Wood Handle Screwdriver Screw Caddy, Cannulated Screw 7.3mm, Thread Length 16mm Centering Sleeve for Tap Measuring Device, 300mm, 7.3mm Cannulated Screw Paraell Wire Guide, 2.8mm Adjustable, 7.3mm Cannulated Screw Instrument Tray, 7.3mm Cannulated Screw and Instrument Trocar, 2.8mm,7.3mm Cannulated Screw Countersink, Cannulated, 7.3mm Cannulated screw Short Reamer Head Guide shaft with Flats Centering Sleeve for Lag Screw Wrench Direct Measuring Device Outside Case, 7.3mm Cannulated Screw and Instrument Standard Reamer Head SHS Impactor Shaft Lag Screw Retaining Rod (For Removal) Hip Screw T-Handle Lag Screw Insertion Wrench Triple Reamer Locking Nut Large Fragment Depth Gauge Hip Screw Drill Guide 12.5mm Tap Lag Screw Retaining Rod (For Insertion) 3.5mm Hexdriver Shaft (Short) 140 Degree Angle Guide Double Drill Guide 2.7/1.25mm Screwdriver Shaft, Cannulated, for Cannulated Screw 4mm HPS Screws and Instruments Case 4mm Cannulate Screws and Instruments Case Handle with Quick Coupling HPS Lag Screws and Plates Case Tap, Cannulated, for Cannulated Screw 4mm Screwdriver, Cannulated, for Cannulated Screw 4mm Countersink, for Cannulated screw 4mm 4.5mm Tap Direct Measuring Device, for Cannulated Screw 4mm Manual surgical instrument; various types of manual Screwdriver Shaft T8, for Cannulated Screw 2.4mm Biomet Microfixation OmniMax MMF System MRI Vision Bolt Variable Tensioned Wire OIC External Fixation System Microware DHS/DCS Plate System Retaining Abutment Screw Activation Key Hexalobular Driver DentaBase DentaBase Abutment Lance Drill DentaMount Pilot Drill QS Screw LORENZ 1MM, 1.5MM, 2MM SYSTEM

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device