BEUDAMED
    FDA Registration Active 🇭🇰 Hong Kong

    I-MEDICAL ASIA COMPANY LIMITED

    Reg #: 3015806723 · FEI: 3015806723 · Expires 2026
    View on FDA
    Products
    50
    Proprietary Names
    34
    Establishment Types
    1
    Classifications
    50

    Registration Details

    Registration Name
    I-MEDICAL ASIA COMPANY LIMITED
    Registration Number
    3015806723
    FEI Number
    3015806723
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Unit 18, 4/F, Block Bm Proficient Industrial Centre, 6 Wan Kwun Road
    City
    Kowloon Bay
    Country
    HK

    Regulatory Submissions

    510(k) Number
    K161371

    Owner / Operator

    Firm Name
    I-Medical Asia Company Limited
    Operator Number
    10085603
    Address
    Unit 18, 4/F, Block Bm Proficient Industrial Centre, 6 Wan Kwun Road
    City
    Kowloon Bay
    State
    HK-NOTA
    Postal Code
    HKG
    Country
    HK

    US Agent

    Business Name
    Arthrex Inc
    Contact Name
    Barry Dietz
    Address
    1370 Creekside Blvd
    City
    Naples
    State
    FL
    ZIP
    34108
    Country
    US
    Email
    [email protected]
    Phone
    800 9337001

    Products

    Device Name Product Code
    Rod, Fixation, Intramedullary And Accessories HSB
    Pin, Fixation, Smooth HTY
    Suture, Nonabsorbable, Synthetic, Polyethylene GAT
    Fastener, Fixation, Nondegradable, Soft Tissue MBI
    Screw, Fixation, Bone HWC
    Plate, Fixation, Bone HRS
    Washer, Bolt Nut HTN
    Staple, Fixation, Bone JDR
    Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment HWE
    Instrument, Biopsy KNW
    Shoulder Prosthesis, Reverse Configuration PHX
    Fastener, Fixation, Biodegradable, Soft Tissue MAI
    Accessories, Arthroscopic NBH
    Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer KRR
    Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer HSX
    Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer MBH
    Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use JQC
    Suture, Nonabsorbable, Silk GAP
    Laparoscope, General & Plastic Surgery GCJ
    Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented HSD
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented KWS
    Cerclage, Fixation JDQ
    Protector, Skin Pressure FMP
    Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained PKC
    Total Shoulder Arthroplasty System QHQ
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    System, X-Ray, Angiographic IZI
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented MBF
    Reamer HTO
    Arthroscope HRX
    Instrument, Manual, Surgical, General Use MDM
    Light, Surgical, Fiberoptic FST
    Shoulder Arthroplasty Implantation System QHE
    System, Image Processing, Radiological LLZ
    Orthopedic Manual Surgical Instrument LXH
    Component, Traction, Non-Invasive KQZ
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    System, Imaging, Pulsed Doppler, Ultrasonic IYN
    Transducer, Ultrasonic, Diagnostic ITX
    Bit, Drill HTW
    Camera, Surgical And Accessories KQM
    Blade, Saw, General & Plastic Surgery, Surgical GFA
    Insufflator, Laparoscopic HIF
    Bur, Surgical, General & Plastic Surgery GFF
    Syringe, Piston FMF
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive OIY
    Bone Wedge PLF
    Apparatus, Traction, Non-Powered HST
    Table And Attachments, Operating-Room BWN

    Proprietary Names

    PCL TIGHTROPE LOW PROFILE PLATE AND SCREW SYSTEM Arthrex Plates, Screws, and Staples Accessories, Arthroscopic Arthrex Knee Systems Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use Arthrex Fracture Plates Arthrex Short Suture Anchors Arthrex Compression Screws laparoscope, general & plastic surgery Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment ARTHREX HUMERAL FRACTURE PLATES AND SCREWS Protector, Skin Pressure Arthrex Fracture System Reamer Arthrex Univers II Shoulder Prosthesis System: Titanium Humeral Heads Instrument, Manual, Surgical, General Use FIBER OPTIC LIGHT GUIDE OR FIBER OPTIC CABLE Orthopedic Manual Surgical Instrument Component, Traction, Non-Invasive Arthrex Tenodesis Button Arthrex 2.5 mm Tenodesis Screw LOW PROFILE SCREWS BIT, DRILL Camera, Surgical And Accessories Blade, Saw, General & Plastic Surgery, Surgical Bur, Surgical, General & Plastic Surgery Arthrex Mesh Plate System MINI TIGHTROPE Arthrex Minimally Invasive Ankle Fusion Plate Arthrex Low Profile Screws Arthrex Distal Radius System Apparatus, Traction, Non-Powered TABLE AND ATTACHMENTS, OPERATING-ROOM

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device