BEUDAMED
    FDA Registration Active 🇨🇳 China

    Hangzhou Fushan Medical Appliance Co., Ltd.

    Reg #: 3006787036 · FEI: 3006787036 · Expires 2026
    View on FDA
    Products
    44
    Proprietary Names
    62
    Establishment Types
    6
    Classifications
    44

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    Registration Details

    Registration Name
    Hangzhou Fushan Medical Appliance Co., Ltd.
    Registration Number
    3006787036
    FEI Number
    3006787036
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    No.1288 South Jinxi Road, Linglong Industrial Park, Lin'an District
    City
    Hangzhou City Zhejiang
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K030927

    Owner / Operator

    Firm Name
    Hangzhou Fushan Medical Appliance Co., Ltd.
    Operator Number
    10022911
    Address
    No.1288 South Jinxi Road, Linglong Industry Park
    City
    Lin'an, Hangzhou
    State
    Zhejiang
    Postal Code
    311301
    Country
    CN
    Correspondent
    Heather Qin

    US Agent

    Business Name
    Regrek LLC
    Contact Name
    Leeyeo Kee
    Address
    19 Holly Cove Ln
    City
    Dover
    State
    DE
    ZIP
    19901
    Country
    US
    Email
    [email protected]
    Phone
    302 6089028

    Products

    Device Name Product Code
    Speculum, Vaginal, Nonmetal HIB
    Holder, Film, X-Ray EGZ
    Vinyl Patient Examination Glove LYZ
    Cannula, Nasal, Oxygen CAT
    Bottle, Collection, Vacuum KDQ
    Catheter, Ventricular, General & Plastic Surgery GBS
    Catheter, Drainage, Intraoral/Extraoral OAJ
    Catheter, Retention Type, Balloon EZL
    Needle, Hypodermic, Single Lumen FMI
    Syringe, Piston FMF
    Adaptor, Ureteral Catheter EYI
    Needle, Conduction, Anesthetic (W/Wo Introducer) BSP
    Laparoscope, Gynecologic (And Accessories) HET
    Endoscope Channel Accessory ODC
    Hysteroscope (And Accessories) HIH
    Laryngoscope, Rigid CCW
    Disinfectant, Medical Devices LRJ
    Operating Room Accessories Table Tray FWZ
    Gauze / Sponge,Nonresorbable For External Use NAB
    Catheter, Balloon Type GBA
    Stylet, Tracheal Tube BSR
    Airway, Oropharyngeal, Anesthesiology CAE
    Bedding, Disposable, Medical KME
    Hysteroscope Accessories NWW
    System, Irrigation, Urological LJH
    Arthroscope HRX
    Snare, Nasal KBE
    Lubricant, Patient KMJ
    Pump, Breast, Non-Powered HGY
    System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile EYZ
    Catheter, Irrigation GBX
    Mask, Oxygen BYG
    Balloon, Epistaxis EMX
    Nebulizer, Medicinal, Non-Ventilatory (Atomizer) CCQ
    Device, Intravascular Catheter Securement KMK
    Retractor, Vaginal HDL
    Catheter And Tip, Suction JOL
    Protector, Ostomy EXE
    Staple, Implantable GDW
    Stapler, Skin QQS
    Retractor GAD
    Anoscope And Accessories FER
    Applicator, Absorbent Tipped, Sterile KXG
    Drape, Surgical, Antimicrobial KKX

    Proprietary Names

    Digital Sensor Sleeves Bitewing Tabs gloves Nasal Oxygen Cannula Outflow Tubing Fluid Management Pack BOTTLE JD-HOOK Safety Stylet Accessory Durrani PVC Chest tube Kit, JD-1000 Chest Drainage Kit JD-1000 Amsino Silicone Catheter pack,tray URETERAL CATHETER foley catheter needle endoscope medical item gauze silicone foley catheter Durrani Silicone Chest Tube Kit, JD-3000 Durrani General Purpose Silicone Drainage Catheter Kit, JD-2000 Endotracheal Tube Stylet Laryngeal Mask Airway Endotracheal Tube bedding seal Silicone Foley Catheter IRRIGATION Nasal Tube, Snare, lubricant Primo Lacto Silicone Round Fluted Drain, Silicone Round Drain, 10Fr-18Fr Silicone Blake Drain,10Fr,15Fr,19Fr,24Fr; Silicone Reservoir,100cc 200cc Silicone Flat Drain,7mm 10mm Silicone Flat Fluted Drain Perforated Hubless Flat Silicone Wound Drain 7mm, 10mm, 13mm, 14mm, Silicone Flat Channel Drain Wound Drain with Trocar 8mm 11mm 13mm silicone wound drainage system with trocar Perforated Round Silicone Wound Drain with adapter 10Fr 12Fr 14Fr 16Fr 18Fr Silicone Channeled Drian with Trocar 10Fr 15Fr 19Fr 24Fr silicone Reservoir 100cc 200cc 150cc 400cc Perforated Hubless Flat Silicone Wound Drain with adapter 7mm NEBULIZER, Nebulizer Mask Kit Oxygen Mask Summit Medical Catheter Balloon Catheter,Silicone Epistaxis Nasal Catheter Nebulizer Kit Nebulizer Mask Dialysis Catheter Dressing Central Venous Catheter Dressing Catheter Fixing dressing CATHETER DRESSING ONETRAC LXS Yankauer SubQ It! Bioabsorbable Skin Closure System - Stapler applicator drape

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Repack or Relabel Medical Device Sterilize Medical Device for Another Party (Contract Sterilizer) Manufacture Medical Device Export Device to the United States But Perform No Other Operation on Device Reprocess Single-Use Device