BEUDAMED
    FDA Registration Active 🇸🇪 Sweden

    501-466 Swelab Alfa Lyse

    Reg #: 3004008703 · FEI: 3004008703 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    7
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    BOULE MEDICAL AB
    Registration Number
    3004008703
    FEI Number
    3004008703
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Domnarvsgatan 4
    City
    Spanga Stockholm
    Country
    SE

    Owner / Operator

    Firm Name
    Boule Diagnostics AB
    Operator Number
    9034165
    Address
    Domnarvsgatan 4
    City
    Spanga
    State
    SE-NOTA
    Postal Code
    SE-163 53
    Country
    SE

    US Agent

    Business Name
    Clinical Diagnostics Solutions
    Contact Name
    Junelle Goldson
    Address
    1800 Nw 65th Ave
    City
    Plantation
    State
    FL
    ZIP
    33313
    Country
    US
    Email
    [email protected]
    Phone
    954 4539139

    Products

    Device Name Product Code
    Products, Red-Cell Lysing Products GGK

    Proprietary Names

    501-466 Swelab Alfa Lyse Swelab Lumi-L1 Lyse 501-464 Medonic M-Series Lyse Swelab Lumi-L2 Lyse Medonic M51-L2 Lyse Medonic M51-L1 Lyse 501-475 Quintus 5-Part Lyse

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Export Device to the United States But Perform No Other Operation on Device