BEUDAMED
    FDA Registration Active 🇨🇳 China

    R9 Digital Color Doppler Ultrasound System

    Reg #: 3004705634 · FEI: 3004705634 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    16
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    SONOSCAPE MEDICAL CORP.
    Registration Number
    3004705634
    FEI Number
    3004705634
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Room 201 & 202, 12th Building, Shenzhen Software Park Phase II, 1 Keji Middle 2nd Road, Yuehai Subdistrict, Nanshan District,
    City
    SHENZHEN Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K221089

    Owner / Operator

    Firm Name
    SONOSCAPE MEDICAL CORP.
    Operator Number
    9063868
    Address
    Room 201 & 202, 12th Building, Shenzhen Software Park Phase II, 1 Keji Middle 2nd Road, Yuehai Subdistrict, Nanshan District,
    City
    Shenzhen
    State
    Guangdong
    Postal Code
    518057
    Country
    CN
    Correspondent
    Toki - Wu

    US Agent

    Business Name
    Bioprober Corporation
    Contact Name
    Xuegong Shi
    Address
    1975 112TH AVE NE STE 101
    City
    Bellevue
    State
    WA
    ZIP
    98004
    Country
    US
    Email
    [email protected]
    Phone
    425 9744253

    Products

    Device Name Product Code
    System, Imaging, Pulsed Doppler, Ultrasonic IYN
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    Transducer, Ultrasonic, Diagnostic ITX

    Proprietary Names

    R9 Digital Color Doppler Ultrasound System P11 Elite Digital Color Doppler Ultrasound System P10 Elite Digital Color Doppler Ultrasound System P12 Elite Digital Color Doppler Ultrasound System P11 Pro Digital Color Doppler Ultrasound System R10 Digital Color Doppler Ultrasound System P12N Digital Color Doppler Ultrasound System P11 Exp Digital Color Doppler Ultrasound System R12/P12N/P11 Exp/P11 Elite/P11 Pro/ R11/P11N/P10 Elite/P10N/R10/P9 Elite/M11/R9 P11N Digital Color Doppler Ultrasound System R11 Digital Color Doppler Ultrasound System P12 Pro Digital Color Doppler Ultrasound System P12 Exp Digital Color Doppler Ultrasound System M11 Digital Color Doppler Ultrasound System P9 Elite Digital Color Doppler Ultrasound System P10N Digital Color Doppler Ultrasound System

    Establishment Types

    Manufacture Medical Device