BEUDAMED
    FDA Registration Active 🇸🇪 Sweden

    BOULE MEDICAL AB

    Reg #: 3004008703 · FEI: 3004008703 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    44
    Establishment Types
    3
    Classifications
    5

    Registration Details

    Registration Name
    BOULE MEDICAL AB
    Registration Number
    3004008703
    FEI Number
    3004008703
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Fagerstagatan 7
    City
    Spanga Stockholm
    Country
    SE

    Regulatory Submissions

    510(k) Number
    K083420

    Owner / Operator

    Firm Name
    Boule Diagnostics AB
    Operator Number
    9034165
    Address
    Fagerstagatan 7
    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
    Diluent, Blood Cell GIF
    Detergent JCB
    Tube, Collection, Capillary Blood GIO
    Counter, Differential Cell GKZ

    Proprietary Names

    501-475 Quintus 5-Part Lyse Medonic M51-L1 Lyse 501-464 Medonic M-Series Lyse 501-466 Swelab Alfa Lyse Swelab Lumi-L2 Lyse Medonic M51-L2 Lyse Swelab Lumi-L1 Lyse 501-292 Quintus 5-Part Diluent Cell-Dyn Emerald Diluent 501-202 CDS Hematology Diluent Medonic M51-D Diluent 501-057 CDS Hematology Diluent 501-069 CDS HEMATOLOGY DILUENT 501-465 Swelab Alfa Diluent 501-201 CDS Hematology Diluent 501-212 Medonic M-Series Diluent 501-052 CDS Hematology Diluent 501-056 CDS Hematology Diluent 501-081 CDS Diluent Sheath Swelab Lumi-D Diluent 501-128 HEMATOLOGY DILUENT 501-133 CDS KX21 Hematology Diluent 501-067 CDS HEMATOLOGY DILUENT 501-208 Swelab Alfa Diluent 501-463 Medonic M-Series Diluent 501-003 HEMATOLOGY DILUENT 501-476 Quintus 5-Part Diluent 501-074 Enzymatic Cleaner Concentrate 501-477 Quintus 5-Part Stopper Cell-Dyn Emerald Cleaner 501-002 ENZYMATIC CLEANER 501-205 CDS Rinse Solution 501-350 Quintus 5-Part Stopper 501-036 Boule Cleaning Kit 501-029 Ac.T Cleaner and Shutdown Solution 501-204 CDS Rinse Solution 501-073 CDS DETERGENT REAGENT 501-064 CDS DETERGENT REAGENT 501-032 ENZYMATIC CLEANER 501-063 ENZYMATIC CLEANER CONCENTRATE Boule EasyCleaner 501-066 CDS DETERGENT REAGENT Boule, MPA Micro Pipettes Plastic Medonic M-series

    Establishment Types

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