BEUDAMED
    FDA Registration Active 🇨🇳 China

    Dongguan Hong De Medical Plastic Products Co. Ltd.

    Reg #: 3010305275 · FEI: 3010305275 · Expires 2026
    View on FDA
    Products
    32
    Proprietary Names
    6
    Establishment Types
    4
    Classifications
    32

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    Registration Details

    Registration Name
    Dongguan Hong De Medical Plastic Products Co. Ltd.
    Registration Number
    3010305275
    FEI Number
    3010305275
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    16 / 19 Yin Song Road, Shang Yuan, Qing Xi
    City
    Dongguan Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K221278

    Owner / Operator

    Firm Name
    Dongguan Hong De Medical Plastic Products Co.
    Operator Number
    10043215
    Address
    16 / 19 Yin Song Road, Shang Yuan, Qing Xi
    City
    Dongguan
    State
    Guangdong
    Postal Code
    523000
    Country
    CN
    Correspondent
    Carol Zhou

    US Agent

    Business Name
    Simcon International LLC
    Contact Name
    Rosanna Lee
    Address
    1200 Townline Rd
    City
    Mundelein
    State
    IL
    ZIP
    60060
    Country
    US
    Email
    [email protected]
    Phone
    847 9492290

    Products

    Device Name Product Code
    Device, Fixation, Tracheal Tube CBH
    Tracheobronchial Suction Catheter Kit OFR
    General Purpose Instrument Tray PXV
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Cover, Barrier, Protective MMP
    Dressing, Wound, Hydrophilic NAC
    Support, Patient Position CCX
    Drape, Surgical, Antimicrobial KKX
    Gown, Surgical FYA
    Instrument, Manual, Surgical, General Use MDM
    Laparoscope, General & Plastic Surgery GCJ
    Collector, Ostomy EXB
    Container, Specimen Mailer And Storage, Non-Sterile NNK
    Transducer, Ultrasonic, Diagnostic ITX
    Container, Specimen, Non-Sterile NNI
    Sheet, Burn FPY
    Bag, Urine Collection, Leg, For External Use, Sterile FAQ
    Catheters, Suction, Tracheobronchial BSY
    Basin, Emesis FNY
    Counter, Sponge, Surgical LWH
    Collector, Urine, (And Accessories) For Indwelling Catheter KNX
    Warmer, Irrigation Solution LHC
    Strap, Head, Gas Mask BTK
    Light, Surgical, Accessories FTA
    Aid, Transfer IKX
    Dressing, Wound, Occlusive NAD
    Drape, Surgical, Exempt PUI
    Non-Surgical Gown OEA
    Lavage, Jet FQH
    Bandage, Cast ITG
    General Surgery Tray LRO
    Holder, Ureteral Catheter EYJ

    Proprietary Names

    Tracheobronchial Suction Catheter Kit Probe Cover Kit COVER PROBE W/GEL & BANDS Specimen Container Warmer, irrigation solution Sterile Burn Sheet

    Establishment Types

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