BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Verifine® Ease Lancing Device, Verifine® Lancing Device

    K Number: K223643 · Decision Feb 21, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    84
    Registration Numbers
    84
    Same Product Code
    23
    Applicant Total
    35
    Review Days
    77

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    Basic Information

    Device Name
    Verifine® Ease Lancing Device, Verifine® Lancing Device
    K Number
    K223643
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4850
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Promisemed Hangzhou Meditech Co., Ltd.
    Date Received
    December 6, 2022
    Decision Date
    February 21, 2023
    Product Code
    QRL
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    QRL Multiple Use Blood Lancet For Single Patient Use Only

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    Other Clearances by Promisemed Hangzhou Meditech Co., Ltd.

    K Number Device Name
    K261196 Promisemed VeriEcto Automatic Biopsy Needles
    K261045 Verifine Safety Lancets
    K254273 Verisafe Safety Sterile Needles (SSN)
    K250192 Verisafe Safety Retractable Insulin Syringes
    K250961 Blood collection tube holders
    K251138 Promisemed Safety Huber Needles
    K243332 Promisemed Safety Huber Needles
    K243806 Safety Winged Blood Collection Sets
    K240675 Endoscopic Injection Needles
    K242632 Verifine® Pen Needles
    Search all 35 clearances from Promisemed Hangzhou Meditech Co., Ltd. →