BEUDAMED
    FDA Registration Active 🇨🇳 China

    BCR-ABL1 (p210) %IS Kit (Digital PCR Method)

    Reg #: 3021269066 · FEI: 3021269066 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    SUZHOU SNIPER MEDICAL TECHNOLOGIES CO., LTD
    Registration Number
    3021269066
    FEI Number
    3021269066
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Unit 301, Building A6, Suzhou BioBAY, No. 218 Xinghu Street, Suzhou Industrial Park
    City
    Suzhou Jiangsu
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K221869

    Owner / Operator

    Firm Name
    Suzhou Sniper Medical Technologies Co., Ltd
    Operator Number
    10083328
    Address
    Unit 301, Building A6, Suzhou BioBAY, No. 218 Xinghu Street, Suzhou Industrial Park
    City
    Suzhou
    State
    Jiangsu
    Postal Code
    215000
    Country
    CN
    Correspondent
    Mars Wu

    Products

    Device Name Product Code
    Droplet Digital Pcr System PHG
    Bcr/Abl1 Monitoring Test OYX

    Proprietary Names

    BCR-ABL1 (p210) %IS Kit (Digital PCR Method)

    Establishment Types

    Manufacture Medical Device