BEUDAMED
    FDA Registration Active 🇨🇳 China

    Hangzhou Primecare Medical Co.,Ltd.

    Reg #: 3014637079 · FEI: 3014637079 · Expires 2026
    View on FDA
    Products
    28
    Proprietary Names
    34
    Establishment Types
    3
    Classifications
    28

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    Registration Details

    Registration Name
    Hangzhou Primecare Medical Co.,Ltd.
    Registration Number
    3014637079
    FEI Number
    3014637079
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Room 408-409, Zancheng Center West, Shangcheng District, 310008 Hangzhou, PEOPLE'S REPUBLIC OF CHINA
    City
    hangzhou Zhejiang
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K232205

    Owner / Operator

    Firm Name
    Hangzhou Primecare Medical Co.Ltd
    Operator Number
    10058286
    Address
    Room 408-409, Zancheng Center west, Shangcheng District, 310008 Hangzhou, PEOPLE'S REPUBLIC OF CHINA
    City
    hangzhou
    State
    Zhejiang
    Postal Code
    310008
    Country
    CN
    Correspondent
    Juan Wu

    US Agent

    Business Name
    3dstocking Inc
    Contact Name
    Wei ZHANG
    Address
    3 Germay Dr Ste 5 Pmb 29339
    City
    Wilmington
    State
    DE
    ZIP
    19804
    Country
    US
    Email
    [email protected]
    Phone
    772 9996108

    Products

    Device Name Product Code
    Tube, Aspirating, Flexible, Connecting BYY
    Urinary Drainage Collection Kit, For Indwelling Catheter FCN
    Container, Specimen, Non-Sterile NNI
    Apparatus, Suction, Single Patient Use, Portable, Nonpowered GCY
    Pump, Infusion, Enteral LZH
    Razor, Surgical LWK
    Gastrointestinal Tubes With Enteral Specific Connectors PIF
    Tubes, Gastrointestinal (And Accessories) KNT
    Lubricant, Patient KMJ
    Dispenser, Liquid Medication KYX
    Speculum, Vaginal, Nonmetal HIB
    Device, Paste-On For Incontinence, Non-Sterile NOA
    Collector, Urine, (And Accessories) For Indwelling Catheter KNX
    Tracheostomy And Nasal Suctioning Kit LRQ
    Bag, Urine Collection, Leg, For External Use, Sterile FAQ
    Syringe, Irrigating (Non Dental) KYZ
    Kit, Surgical Instrument, Disposable KDD
    Device, Paste-On For Incontinence, Sterile EXI
    Suture Removal Kit MCZ
    Catheter, Retention Type, Balloon EZL
    Catheters, Suction, Tracheobronchial BSY
    Enema Kit FCE
    Catheter And Tip, Suction JOL
    Container, Specimen, Sterile FMH
    Medical Device Data System OUG
    Uroflowmeter EXY
    Intra-Abdominal Pressure Monitoring Device PHU
    Catheter Care Tray OHR

    Proprietary Names

    Suction connecting tube; Extension tube Urethral Catheterization Tray (w/ or w/o Catheter) Speicmen Collector Urine/Stool, Non-Str; Specimen Container APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED Enteral feeding pump sets razor prep disposable, razor twin blade Enteral feeding sets Lub Jelly Syringe Enteral Specific transition connector Medication Bottle Adaptor Disposable Vaginal Speculum Extension Set Urine collector pediatric NS Trachestomy care kit Leg Bag, Drainage Bag, Urinary Drainage Bag Irrigation tray, irrigation syringe, Ear Ulcer syringe Laceration Tray IV START KIT Central Line Trays skin scrub Tray Dressing change kit Shave Prep Kit Convenience Kits instrument pack Urine collector pediatric st Skin Staple removal Kit; Suture removal kit /tray Latex Foley catheters, Silicone Foley catheters Suction catheter kit Pre-filled syringe ENEMA BUCKET 1500ML W/SOAP; ENEMA SET Suction Yankauer Specimen container, STR Urine Meter Drainage Bag;Accuryn Monitoring System; Accuryn SmartFoley IAP UO Temp Tray System; Accuryn SmartFoley UO Te Catheter Care Tray, Foley insertion tray

    Establishment Types

    Manufacture Medical Device Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device for Another Party (Contract Manufacturer)