BEUDAMED
    FDA Registration Active 🇸🇪 Sweden

    CoroFlow Cardiovascular System

    Reg #: 3017845286 · FEI: 3017845286 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    COROVENTIS RESEARCH AB
    Registration Number
    3017845286
    FEI Number
    3017845286
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Ulls vag 29A
    City
    Uppsala
    Country
    SE

    Regulatory Submissions

    510(k) Number
    K201881

    Owner / Operator

    Firm Name
    COROVENTIS RESEARCH AB
    Operator Number
    10079245
    Address
    Ulls vag 29A
    City
    Uppsala
    State
    SE-C
    Postal Code
    75651
    Country
    SE
    Correspondent
    Johan Svanerud

    US Agent

    Business Name
    Emergo Global Representation LLC
    Contact Name
    Yong Sun
    Address
    2500 Bee Cave Rd., Bldg. 1, Ste. 300
    City
    Austin
    State
    TX
    ZIP
    78746
    Country
    US
    Email
    [email protected]
    Phone
    512 3279997

    Products

    Device Name Product Code
    Medical Device Data System OUG
    Computer, Diagnostic, Programmable DQK

    Proprietary Names

    CoroFlow Cardiovascular System

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198