BEUDAMED
    FDA Registration Active 🇪🇸 Spain

    BIOMERIEUX SPAIN

    Reg #: 3009307598 · FEI: 3009307598 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    47
    Establishment Types
    1
    Classifications
    6

    Registration Details

    Registration Name
    BIOMERIEUX SPAIN
    Registration Number
    3009307598
    FEI Number
    3009307598
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Isaac Newton, 6
    City
    Tres Cantos Madrid (Province)
    Country
    ES

    Regulatory Submissions

    510(k) Number
    K151688

    Owner / Operator

    Firm Name
    BIOMERIEUX SA
    Operator Number
    8020790
    Address
    Chemin De L Orme
    City
    Marcy L Etoile
    State
    Rhone
    Postal Code
    69280
    Country
    FR

    US Agent

    Business Name
    BioMerieux, SA
    Contact Name
    Nathan Hardesty
    Address
    595 Anglum Rd, Bldg. 1, 2nd Flr.
    City
    Hazelwood
    State
    MO
    ZIP
    63042
    Country
    US
    Email
    [email protected]
    Phone
    314 7318666

    Products

    Device Name Product Code
    Discs, Strips And Reagents, Microorganism Differentiation JTO
    Kit, Screening, Staphylococcus Aureus JWX
    Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar JSO
    Culture Media, Selective And Differential JSI
    Culture Media, Selective Broth JSD
    Kit, Screening, Urine JXA

    Proprietary Names

    API CORYNE REACTIFS VP1 VP2 4AMP API Reagents (Multiple) ZYM B X2 NIN X2 API RAPIDEC Staph VP1 VP2 Reagents API Strep, Coryne, Zym and NH VPA VPB Reagents Rapid ID32 Strep API LISTERIA API CAMPY API SUSP API ZYM HUILE DE PARAFFINE API RAPID ID 32 STREP REACTIFS NIT 1+NIT 2 4AMP PYZ 2 AMP API NACL 0.85% MCFARLAND STANDARD BCP POURPRE DE BROMOCRESOL1AMP EHR (EHRLICH) 1 AMP API 20 STREP REACTIFS VPA VPB 2AMP API NH NIN 2 AMP XYL (XYLENE) REACTIF TDA 2AMP API Mineral Oil ID COLOR CATALASE JAMES 2 AMP ZN (POUDRE DE ZINC) FB (FAST BLUE BB) 2 AMP Slidex Staph Plus ID 32 Staph API STAPH chromID MRSA / chromID S. aureus chromID MRSA CHROMID Candida Agar chromID P. aeruginosa agar NTM Elite agar chromID CARBA ChromID S. aureus Elite Agar chromID C. Difficile Todd Hewitt + Antibiotics (TODD H-T) chromID CPS Elite CHROMID CPS ELITE / COL CNA

    Establishment Types

    Manufacture Medical Device