BEUDAMED
    FDA Registration Active 🇨🇳 China

    Suzhou Elite Precision Machinery Co., Ltd.

    Reg #: 3011295718 · FEI: 3011295718 · Expires 2026
    View on FDA
    Products
    35
    Proprietary Names
    45
    Establishment Types
    2
    Classifications
    35

    Registration Details

    Registration Name
    Suzhou Elite Precision Machinery Co., Ltd.
    Registration Number
    3011295718
    FEI Number
    3011295718
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    No.498 Fengxing Rd, Huaqiao Town
    City
    Kunshan Jiangsu
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K150241

    Owner / Operator

    Firm Name
    Suzhou Elite Precision Machinery Co., Ltd.
    Operator Number
    10048840
    Address
    No.498 Fengxing Rd, Huaqiao Town
    City
    Kunshan
    State
    Jiangsu
    Postal Code
    215332
    Country
    CN

    US Agent

    Business Name
    Registrar Corp
    Contact Name
    David Lennarz
    Address
    144 Research Drive
    City
    Hampton
    State
    VA
    ZIP
    23666
    Country
    US
    Email
    [email protected]
    Phone
    757 2240177

    Products

    Device Name Product Code
    Component, Traction, Non-Invasive KQZ
    Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer KRR
    Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer HSX
    Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer NPJ
    Fastener, Fixation, Nondegradable, Soft Tissue MBI
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH
    Pin, Fixation, Threaded JDW
    Screw, Fixation, Bone HWC
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH
    Accessories, Arthroscopic NBH
    Plate, Fixation, Bone HRS
    Instrument, Bending Or Contouring HXP
    Orthopedic Manual Surgical Instrument LXH
    Prosthesis, Hip, Hemi-, Femoral, Metal KWL
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented JDI
    Prosthesis, Hip, Femoral Component, Cemented, Metal JDG
    Cerclage, Fixation JDQ
    Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate MEH
    Mesh, Surgical, Acetabular, Hip, Prosthesis JDJ
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented LWJ
    Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer KWZ
    Prosthesis, Hip, Hemi-, Femoral, Metal Ball LZY
    Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous MBL
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO
    Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented KWY
    Screwdriver HXX
    Guide, Surgical, Instrument FZX
    Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component KTT
    Software For Diagnosis/Treatment OSN
    Template HWT
    Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer MBH
    Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer KRO
    Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer HRY
    Prosthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Polymer KRQ
    Passer HWQ

    Proprietary Names

    3134174 JOURNEY II UNI 72202755 72202758 72202756 72202757 JOURNEY OTHER EXTERNAL FIXATION ILIZAROV SYSTEMS 72201805 OR30 Dual mobility trial insert locking ring 22 ID 72201743 72201742 72201741 810599701 7207281 72201590 14803 72201727 8005665 ANTHEM PERI-LOC PERIL-LOC EXTENDER O/MFG TRIAL SHELL HANDLE Set Screw Driver JOURNEY TKA AP FEM CUT BLK KNOB O/MFG PATELLA HOUSING WELD TIB ART ISRT IMP/EXT S/A REFLECTION IMHS OR30 Dual Mobility System ILIZAROV TSF 7209214 14412 Genesis II oval resurfacing patellar trial GENESIS Gll DCF VRBL SZ GUIDE LT Gll DCF VRBL SZ GUIDE RT 72202193 72202192 72202191 72201882 72201881

    Establishment Types

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