BEUDAMED
    FDA Registration Active 🇩🇰 Denmark

    Ambu A/S

    Reg #: 9610691 · FEI: 3002806359 · Expires 2026
    View on FDA
    Products
    27
    Proprietary Names
    100
    Establishment Types
    3
    Classifications
    27

    Registration Details

    Registration Name
    Ambu A/S
    Registration Number
    9610691
    FEI Number
    3002806359
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Baltorpbakken 13
    City
    Ballerup Hovedstaden
    Country
    DK

    Regulatory Submissions

    510(k) Number
    K923976

    Owner / Operator

    Firm Name
    AMBU A/S
    Operator Number
    8010067
    Address
    13 BALTORPBAKKEN, --
    City
    BALLERUP
    State
    DK-NOTA
    Postal Code
    DK-2750
    Country
    DK

    US Agent

    Business Name
    Ambu Inc
    Contact Name
    Sanjay Parikh
    Address
    6721 Columbia Gateway Drive, Suite 200
    City
    Columbia
    State
    MD
    ZIP
    21046
    Country
    US
    Email
    [email protected]
    Phone
    410 7686464 ext. 1136

    Products

    Device Name Product Code
    Tape And Bandage, Adhesive KGX
    Attachment, Breathing, Positive End Expiratory Pressure BYE
    Electrode, Needle GXZ
    Electrode, Cutaneous GXY
    Laryngoscope, Rigid CCW
    Ureteroscope And Accessories, Flexible/Rigid FGB
    Endoscopic Video Imaging System/Component, Gastroenterology-Urology FET
    Gastroscope And Accessories, Flexible/Rigid FDS
    Ventilator, Emergency, Manual (Resuscitator) BTM
    Bronchoscope (Flexible Or Rigid) EOQ
    Cable, Electrode IKD
    Cystoscope And Accessories, Flexible/Rigid FAJ
    Mask, Gas, Anesthetic BSJ
    Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector) CBI
    Laryngoscope Kit OGH
    Duodenoscope And Accessories, Flexible/Rigid FDT
    Orthosis, Cervical IQK
    Nasopharyngoscope (Flexible Or Rigid) EOB
    Monitor, Airway Pressure (Includes Gauge And/Or Alarm) CAP
    Cardiopulmonary Resuscitation Aid Kit OEV
    Electrode, Needle, Diagnostic Electromyograph IKT
    Mask, Oxygen BYG
    Airway, Oropharyngeal, Anesthesiology CAE
    Electrode, Electrocardiograph DRX
    Container, Specimen, Sterile FMH
    Accessories, Photographic, For Endoscope (Exclude Light Sources) FEM
    Support, Patient Position CCX

    Proprietary Names

    Skin Fix Airlife PEEP Valve Ambu PEEP 20 Valve Ambu PEEP Valve Monopolar Neuroline Monopolar Needle Electrode Monopolar Needle Electrode Neuroline Neuroline 720 Ambu® aBox™ 2 Ambu® SureSight® Blade Miller Ambu® SureSight® Data Cable Ambu® SureSight® Connect Ambu® SureSight® Blade Hyperangulated Channeled Ambu® SureSight® Mobile Ambu® SureSight® Battery Charger Ambu® aView™ 2 Advance Ambu® SureSight® Blade Hyperangulated Ambu® SureSight® Blade MAC Ambu® aScope™ 5 Uretero (Standard Deflection) Ambu® aScope™ 5 Uretero (Reverse Deflection) Ambu aScope Gastro Ambu aBox2 Ambu aScope Gastro Large Ambu aBox 2 Ambu Spur II Ambu aScope 4 Broncho Slim Ambu aScope 4 Broncho Ambu aScope 4 Broncho Large Ambu aScope 4 Broncho Regular Ambu aView Monitor Neuroline Cable Ambu Neuroline Cable aScope 4 Broncho Regular Sampler Set 5/2.2 aScope 4 Broncho Large Sampler Set 5.8/2.8 Neuroline 700 Neuroline 710 Ambu aScope 5 Broncho HD 5.6/2.8 Ambu aScope 5 Broncho HD 5/2.2 Ambu King Mask Ambu® aScope™ 5 Cysto HD Ambu® aScope™ 5 Broncho HD 5.6/2.8 Ambu® aScope™ 5 Broncho HD 5/2.2 Neuroline 715 Ambu Mark IV Resuscitator Mark IV Ambu VivaSight 2 DLT Ambu® SureSight® Mobile Mini Kit Ambu® SureSight® Mobile Kit Ambu Mark IV Baby Resuscitator Ambu aScope Duodeno 2 Ambu Mini Perfit Ace Ambu Redi Ace Adult Ambu Perfit Ambu Perfit Ace Ambu Redi Ace Mini Ambu aScope 4 Cysto Ambu aScope 4 RhinoLaryngo Intervention Ambu Disposable Pressure Manometer Ambu® SPUR® II Ambu® Mark IV Neuroline Inoject Needle Electrode Inoject Inoject Needle Electrode Ambu aScope 4 RhinoLaryngo Slim Ambu Disposable Face Mask Ambu Silicone Face Mask Neuroline Twisted Pair Subdermal Needle Electrode Neuroline Subdermal Needle Electrode Twisted Pair Subdermal Needle Electrode Subdermal Needle Electrode Ambu Reusable PEEP valve AMBU LARYNGEAL MASK Ambu AuraStraight Ambu AuraFlex Ambu Aura40 Ambu Aura-i Ambu AuraGain Ambu AuraOnce ECG Electrodes Ambu BlueSensor Ambu WhiteSensor aScope BronchoSampler 60 SC Neuroline Cup Electrode Cup Electrode Ambu® aScope™ 5 Broncho 4.2/2.2 Ambu® aScope™ 5 Broncho 2.7/1.2 Ambu aScope 5 Broncho HD 5.6/2.8 Sampler Set Ambu aScope 5 Broncho HD 5/2.2 Sampler Set Ambu aView 2 Advance Ground Neuroline Ground Electrode Ground Electrode HEAD WEDGE AMBU HEAD WEDGE AMBU DISPOSABLE HEAD IMMOBILIZER Concentric Needle Electrode Neuroline Concentric Needle Electrode Concentric Ambu® aScope™ 5 Broncho 4.2/2.2 Sampler Set

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Foreign Private Label Distributor Export Device to the United States But Perform No Other Operation on Device