BEUDAMED
    FDA Registration Active 🇨🇳 China

    Sapphire II Pro Coronary Dilatation Catheter

    Reg #: 3003775186 · FEI: 3003775186 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    OrbusNeich Medical (Shenzhen) Co., Ltd.
    Registration Number
    3003775186
    FEI Number
    3003775186
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No.1st Jinkui Road, FUTIAN FREE TRADE ZONE, Shenzhen, China;, Floor 1 and Floor 3, Tower D, Tong'an industrial park, No.124, Yonghe Rd., Baoan, Shenzhen, China
    City
    SHENZHEN Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K180921

    Owner / Operator

    Firm Name
    ORBUSNEICH MEDICAL CO. LTD (HONG KONG)
    Operator Number
    9050384
    Address
    Units 303 &305, 3/F, Building 20E Hong Kong Science Park Shatin, N.T., Hong Kong, No. 27-31 Au Pui Wan Street Fo Tan, N.T. HONG KONG SAR
    City
    Hong Kong
    State
    HK-NOTA
    Postal Code
    --
    Country
    HK
    Correspondent
    Denise Lau

    US Agent

    Business Name
    OrbusNeich Medical, Inc.
    Contact Name
    Amanda Kellar
    Address
    3350 SW 148th Ave, Suite 110, Miramar, FL 33027, US
    City
    Miramar
    State
    FL
    ZIP
    33027
    Country
    US
    Email
    [email protected]
    Phone
    954 6477910

    Products

    Device Name Product Code
    Catheter, Angioplasty, Peripheral, Transluminal LIT
    Catheters, Transluminal Coronary Angioplasty, Percutaneous LOX

    Proprietary Names

    Sapphire II Pro Coronary Dilatation Catheter

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device