BEUDAMED
    FDA Registration Active 🇲🇽 Mexico

    MaxAir Surgical Helmet System

    Reg #: 3015468759 · FEI: 3015468759 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SYNTECH DE BAJA CALIFORNIA, S De RL DE CV
    Registration Number
    3015468759
    FEI Number
    3015468759
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Blvd. Federico Benetiz 15334-1A
    City
    Col. San Antonio Oeste Mexico
    Country
    MX

    Regulatory Submissions

    510(k) Number
    K040485

    Owner / Operator

    Firm Name
    Syntech De Baja California
    Operator Number
    10025436
    Address
    17171 daimler, ave
    City
    Irvine
    State
    CA
    Postal Code
    92614
    Country
    US
    Correspondent
    Nick H Herbert

    Products

    Device Name Product Code
    Gown, Surgical FYA

    Proprietary Names

    MaxAir Surgical Helmet System

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)