BEUDAMED
    FDA Registration Active 🇸🇪 Sweden

    MAQUET CRITICAL CARE AB

    Reg #: 8010042 · FEI: 3002808128 · Expires 2026
    View on FDA
    Products
    22
    Proprietary Names
    31
    Establishment Types
    4
    Classifications
    22

    Registration Details

    Registration Name
    MAQUET CRITICAL CARE AB
    Registration Number
    8010042
    FEI Number
    3002808128
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    ROENTGENVAGEN 2
    City
    SOLNA Stockholm
    Country
    SE

    Regulatory Submissions

    510(k) Number
    K112448

    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
    Absorber, Carbon-Dioxide BSF
    Computer, Diagnostic, Pre-Programmed, Single-Function DXG
    Filter, Bacterial, Breathing-Circuit CAH
    Tubing, Pressure And Accessories BYX
    Ventilator, Continuous, Facility Use CBK
    Gastrointestinal Tubes With Enteral Specific Connectors PIF
    Humidifier, Respiratory Gas, (Direct Patient Interface) BTT
    Probe, Thermodilution KRB
    Drain, Tee (Water Trap) BYH
    Tubes, Gastrointestinal (And Accessories) KNT
    Nebulizer (Direct Patient Interface) CAF
    Compressor, Air, Portable BTI
    Cannula, Nasal, Oxygen CAT
    Bag, Reservoir BTC
    Strap, Head, Gas Mask BTK
    Set, Tubing And Support, Ventilator (W Harness) BZO
    Condenser, Heat And Moisture (Artificial Nose) BYD
    Sv70 Ventilator MNT
    Circuit, Breathing (W Connector, Adaptor, Y Piece) CAI
    Gas-Machine, Anesthesia BSZ
    Mask, Gas, Anesthetic BSJ
    Transducer, Blood-Pressure, Extravascular DRS

    Proprietary Names

    Absorber FLOW-i Servo Guard Edi Catheter ENFit MR850 Watertrap reusable Servo-u/n Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator System 4.1 Miniflow adapter Nasal prongs size XS, S, M, M-wide, L, XL, L-wide Breathing Bag Anesthesia, Disposable Breathing Bag set Anesthesia, Reusable Breathing Bag Anesthesia, Reusable SERVO-U/n Servo Humidifier 173 Servo Humidifier 172 Servo Humidifier 163 Servo Humidifier 162 Servo Humidifier 161 Servo-air Lite Ventilator System F&P 950 Respiratory humidifier Breathing system Gas samplning line Breathing circuit Set of breathing circuit anesthesia FLOW-i 4.2 FLOW-i C20 FLOW-i C30 FLOW-i C40 Flow Family Anesthesia System 4.7; Models Flow-c, Flow-e, Flow-i Servo-air 4 Ventilator System Anesthesia mask, Reusable Anesthesia mask, Disposable

    Establishment Types

    Manufacture Medical Device Export Device to the United States But Perform No Other Operation on Device Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198