BEUDAMED
    FDA Registration Active 🇨🇳 China

    BROSMED MEDICAL CO.,LTD

    Reg #: 3010391265 · FEI: 3010391265 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    9
    Establishment Types
    3
    Classifications
    4

    Registration Details

    Registration Name
    BROSMED MEDICAL CO.,LTD
    Registration Number
    3010391265
    FEI Number
    3010391265
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    15th Building, SMEs Venture Park, SongShan Lake Hi-Tech Industrial Development Zone
    City
    Dongguan Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K141025

    Owner / Operator

    Firm Name
    Brosmed Medical Co.,Ltd
    Operator Number
    10044695
    Address
    15th Building, SMEs Venture Park, SongShan Lake Hi-Tech Industrial Development Zone
    City
    Dongguan
    State
    Guangdong
    Postal Code
    523808
    Country
    CN

    US Agent

    Business Name
    Registrar Corp
    Contact Name
    David Lennarz
    Address
    144 Research Drive
    City
    Hampton
    State
    VA
    ZIP
    23666
    Country
    US
    Email
    [email protected]
    Phone
    757 2240177

    Products

    Device Name Product Code
    Catheters, Transluminal Coronary Angioplasty, Percutaneous LOX
    Syringe, Balloon Inflation, Exempt PTM
    Catheter, Angioplasty, Peripheral, Transluminal LIT
    Catheter, Percutaneous, Cutting/Scoring PNO

    Proprietary Names

    Balloon Inflation Device SABER 14 PTA Dilatation Catheter; SABERX 14 PTA Dilatation Catheter Apollo Balloon Dilatation Catheter Aperi NC Balloon Dilatation Catheter Castor, Achilles, and Hermes NC PTA Balloon Dilatation Catheters Aperi NC Balloon Dilatation Cathter Polux, Minerva, and Atropos PTA Balloon Dilatation Catheter Artimes pro Balloon Dilatation Cathter Aperi SC Balloon Dilatation Catheter

    Establishment Types

    Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device for Another Party (Contract Manufacturer)