BEUDAMED
    FDA Registration Active 🇸🇪 Sweden

    Servo-u/n

    Reg #: 8010042 · FEI: 3002808128 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    MAQUET CRITICAL CARE AB
    Registration Number
    8010042
    FEI Number
    3002808128
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    ROENTGENVAGEN 2
    City
    SOLNA Stockholm
    Country
    SE

    Regulatory Submissions

    510(k) Number
    K180098

    Owner / Operator

    Firm Name
    Maquet Critical Care AB
    Operator Number
    8010042
    Address
    ROENTGENVAGEN 2
    City
    SOLNA
    State
    Stockholm
    Postal Code
    SE-17154
    Country
    SE

    Products

    Device Name Product Code
    Ventilator, Continuous, Facility Use CBK

    Proprietary Names

    Servo-u/n

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device