BEUDAMED
    FDA Registration Active 🇭🇰 Hong Kong

    ORBUSNEICH MEDICAL CO. LTD (HONG KONG)

    Reg #: 3015002281 · FEI: 3015002281 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    13
    Establishment Types
    2
    Classifications
    5

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    Registration Details

    Registration Name
    ORBUSNEICH MEDICAL CO. LTD (HONG KONG)
    Registration Number
    3015002281
    FEI Number
    3015002281
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Units 303 &305, 3/F, Building 20E, Hong Kong Science Park, Shatin, N.t., Hong Kong, No. 27-31 Au Pui Wan Streeet
    City
    Fo Tan, N.T.
    Country
    HK

    Regulatory Submissions

    510(k) Number
    K233499
    PMA Number
    P200041

    Owner / Operator

    Firm Name
    OrbusNeich Medical Co. Ltd (Hong Kong)
    Operator Number
    10059958
    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
    852
    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
    Catheters, Transluminal Coronary Angioplasty, Percutaneous LOX
    Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring NWX
    Catheter, Percutaneous DQY
    Catheter, Angioplasty, Peripheral, Transluminal LIT
    Catheter, Percutaneous, Cutting/Scoring PNO

    Proprietary Names

    Sapphire NC ULTRA Coronary Dilatation Catheter Scoreflex NC Scoring PTCA Catheter Teleport Microcatheter Scoreflex PTA Scoring Balloon Catheter Sapphire II PRO Balloon Dilatation Catheter Jade PTA Balloon Dilatation Catheter Sapphire NC 24 Coronary Dilatation Catheter Teleport Glide Microcatheter Teleport XT Microcatheter JADE PLUS PTA Balloon Dilatation Catheter Sapphire II Pro Coronary Dilatation Catheter Sapphire ULTRA Coronary Dilatation Catheter COREPASS Modular Microcatheter

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Complaint File Establishment per 21 CFR 820.198