BEUDAMED
    FDA Registration Active 🇨🇳 China

    PROMISEMED HANGZHOU MEDITECH CO.,LTD.

    Reg #: 3010515547 · FEI: 3010515547 · Expires 2026
    View on FDA
    Products
    21
    Proprietary Names
    61
    Establishment Types
    3
    Classifications
    21

    Registration Details

    Registration Name
    PROMISEMED HANGZHOU MEDITECH CO.,LTD.
    Registration Number
    3010515547
    FEI Number
    3010515547
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    No. 1388 Cangxing Street,, Cangqian Community, Yuhang District
    City
    Hangzhou Zhejiang
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K191853

    Owner / Operator

    Firm Name
    Promisemed Hangzhou Meditech Co.,Ltd.
    Operator Number
    10045479
    Address
    No. 1388 Cangxing Street, Cangqian Community, Yuhang District
    City
    Hangzhou
    State
    Zhejiang
    Postal Code
    311121
    Country
    CN
    Correspondent
    Frank Zhang

    US Agent

    Business Name
    PROMISEMED USA
    Contact Name
    Robert Wernsman
    Address
    506 W. Rhapsody Dr.
    City
    San Antonio
    State
    TX
    ZIP
    78216
    Country
    US
    Email
    [email protected]
    Phone
    954 7320415

    Products

    Device Name Product Code
    Instrument, Biopsy KNW
    Needle, Hypodermic, Single Lumen FMI
    Injector, Pen NSC
    Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature FMK
    Syringe, Irrigating (Non Dental) KYZ
    Insulin Vial Protector/Holder OJL
    Set, Administration, Intravascular FPA
    Tubes, Vials, Systems, Serum Separators, Blood Collection JKA
    Forceps, Biopsy, Non-Electric FCL
    Multiple Use Blood Lancet For Single Patient Use Only QRL
    Hemostatic Metal Clip For The Gi Tract PKL
    Syringe, Piston FMF
    Non-Coring (Huber) Needle PTI
    Gauze / Sponge,Nonresorbable For External Use NAB
    Syringe, Antistick MEG
    Endoscopic Injection Needle, Gastroenterology-Urology FBK
    Biopsy Needle FCG
    System, Blood Collection, Vacuum-Assisted, Manual KST
    Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature QRK
    Container, Sharps MMK
    Needle, Aspiration And Injection, Disposable GAA

    Proprietary Names

    Verisafe Safety Sterile Needles Enfit oral syringe Catheter tip syringe Verifine Cooler Travel Case Sensifine Pen Tips TonmiCare PLUS Pen Needles Sensifine Pen Needles Verifine Plus Insulin Pen Needles TonmiCare Pen Needles Verifine Insulin Pen Needles Verifine Pen Needles Verifine Plus Pen Needles TonmiCare Pen Tips Sensifine Lancing Device Verifine Lancing Device VeriEndo Single Use Biopsy Forceps Sol-M Lancing Device VeriEndo Single Use Hemoclips Promisemed Safety Huber Needle Dolpbay Insulin Syringe SOL-CARE Safety Shield Blood Collection Tube Holder Medline Huber Needle with Safety Click Advantage JetCan Safety Huber Needles Promisemed Insulin pen needle Verifine Sterile Gauze Pads ReliOn Sterile Gauze Pads SOL-GUARD Auto-Disable Syringe w/Fixed Needle Hartman Medical Group Blood Transfer Device VeriEndo Endoscopic Injection Needles ONE-CARE Safety Insulin Syringes One-Care OPTI Safety Insulin Syringes ONE-CARE OPTI TB Safety Syringes Promisemed X-Safety Pen Needle Advocate Insulin Pen Needles Verifine Safety Retractable Insulin Syringes VeriSafe Safety Sterile Syringes Promisemed Safety Pen Needle TonmiCare Syringes GLUCO-CARE Insulin Syringe TonmiCare Insulin Syringe Verifine Insulin Syringes Esamita Insulin Syringe Member's Mark Insulin Syringes Moiscckel 1ml/cc Disposable Syringe with 30Ga 1/2" (12mm) Needle Sensifine Syringes Moiscckel 1ml/cc Disposable Syringe with 30Ga 5/16" (8mm) Needle Moiscckel 1ml/cc Disposable Syringe with 31Ga 5/16" (8mm) Needle SAFEFINE Insulin Syringes DolpBay Insulin Syringe Easy Glide Insulin Syringe Sensifine Safety Lancet VeriFine Safety Lancet Verifine Blood Lancets Sensifine Blood Lancets Promisemed Sharps Container Verifine Sharps Container Safefine Sharps Container YDSDUTE Sharps Container Sensifine Sharps Container Verisafe Safety sterile needles Verifine blunt needle

    Establishment Types

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