BEUDAMED
    FDA Registration Active 🇨🇳 China

    Areus™ Endoscopic Ultrasound Aspiration Needle(FNA)

    Reg #: 3013440400 · FEI: 3013440400 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Micro-Tech (Nanjing) Co., Ltd.
    Registration Number
    3013440400
    FEI Number
    3013440400
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No. 199 Medicine Valley Avenue, Nanjing National Hi-Tech, Industrial Development Zone
    City
    Nanjing Jiangsu
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K172309

    Owner / Operator

    Firm Name
    Micro-Tech (Nanjing) Co., Ltd.
    Operator Number
    9067602
    Address
    No.10, Gaoke Third Road, Nanjing National Hi-Tech Industrial Development Zone
    City
    Nanjing
    State
    Jiangsu
    Postal Code
    210032
    Country
    CN
    Correspondent
    Sally - He

    Products

    Device Name Product Code
    Biopsy Needle FCG
    Endoscopic Ultrasound System, Gastroenterology-Urology ODG

    Proprietary Names

    Areus™ Endoscopic Ultrasound Aspiration Needle(FNA) Trident™ Endoscopic Ultrasound Biopsy Needle(FNB)

    Establishment Types

    Manufacture Medical Device