BEUDAMED
    FDA Registration Active 🇪🇸 Spain

    KIRO GRIFOLS, S.L.

    Reg #: 3011802635 · FEI: 3011802635 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    4
    Establishment Types
    3
    Classifications
    2

    Registration Details

    Registration Name
    KIRO GRIFOLS, S.L.
    Registration Number
    3011802635
    FEI Number
    3011802635
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Polo de Innovacion Garaia, Goiru Kalea 1, Edificio B
    City
    Arrasate-Mondragon Guipuzcoa
    Country
    ES

    Regulatory Submissions

    510(k) Number
    K152441

    Owner / Operator

    Firm Name
    KIRO GRIFOLS, S.L.
    Operator Number
    10049581
    Address
    Polo de Innovacion Garaia, Goiru Kalea 1, Edificio B
    City
    Arrasate-Mondragon
    State
    Guipuzcoa
    Postal Code
    20500
    Country
    ES
    Correspondent
    Borja Lizari

    US Agent

    Business Name
    Grifols USA, LLC
    Contact Name
    Nuria Sola Tapias
    Address
    79 TW Alexander Drive Building 4101
    City
    Durham
    State
    NC
    ZIP
    27709
    Country
    US
    Email
    [email protected]
    Phone
    213 3043852

    Products

    Device Name Product Code
    System/Device, Pharmacy Compounding NEP
    Set, I.V. Fluid Transfer LHI

    Proprietary Names

    KIRO Oncology US KIRO Link KIRO Fill US KIRO Set

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility