Ambu A/S

FDA Device Registration & Listing · Ballerup Hovedstaden, DK · Registration 9610691

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
9610691
FEI Number
3002806359
Entity Name
Ambu A/S
City/State/Country
Ballerup Hovedstaden, DK
Establishment Address
Baltorpbakken 13, Ballerup Hovedstaden DK-2750, DK
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
AMBU A/S (Owner Number: 8010067)
Owner / Operator Contact Address
13 BALTORPBAKKEN, --, BALLERUP, DK-NOTA DK-2750, DK
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K051529
PMA Number
N/A

All Registered 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® aBox™ 2 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 Neuroline 700 Neuroline 710 Ambu aScope 5 Broncho HD 5.6/2.8 Ambu aScope 5 Broncho HD 5/2.2 Ambu aBox 2 Ambu King Mask Ambu® aScope™ 5 Cysto HD Ambu® aView™ 2 Advance Ambu® aScope™ 5 Broncho HD 5.6/2.8 Ambu® aScope™ 5 Broncho HD 5/2.2 Neuroline 715 Neuroline Ambu Mark IV Resuscitator Mark IV Ambu VivaSight 2 DLT Ambu® SureSight® Mobile Mini Kit Ambu® SureSight® Mobile Kit Ambu Mark IV Baby Resuscitator Mark IV Ambu aScope Duodeno 2 Ambu aBox 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® aView™ 2 Advance Ambu® aScope™ 5 Uretero (Reverse Deflection) Ambu® aScope™ 5 Uretero (Standard Deflection) Ambu Disposable Pressure Manometer Ambu® SPUR® II Ambu® Mark IV Neuroline Inoject Needle Electrode Inoject Inoject Needle Electrode Ambu aScope 4 RhinoLaryngo Slim Ambu® aScope™ 5 Cysto HD Ambu® aView™ 2 Advance Ambu Disposable Face Mask Ambu Silicone Face Mask Neuroline Twisted Pair Subdermal Needle Electrode Neuroline Neuroline Subdermal Needle Electrode Twisted Pair Subdermal Needle Electrode Subdermal Needle Electrode Ambu Reusable PEEP valve Ambu® aBox™ 2 Ambu® aScope™ 5 Cysto HD 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 Neuroline Ambu® aBox™ 2 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 Neuroline Ground Electrode

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KGX Tape And Bandage, Adhesive General Hospital Class 1 880.5240 2005-03-28
BYE Attachment, Breathing, Positive End Expiratory Pressure Anesthesiology Class 2 868.5965 2008-02-07
GXZ Electrode, Needle Neurology Class 2 882.1350 2007-12-27
GXY Electrode, Cutaneous Neurology Class 2 882.1320 2009-12-09
CCW Laryngoscope, Rigid Anesthesiology Class 1 868.5540 2013-03-13
FGB Ureteroscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2024-06-25
FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2024-06-25
FDS Gastroscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2022-02-09
FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2022-02-09
FDS Gastroscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2024-04-08
FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2024-04-08
BTM Ventilator, Emergency, Manual (Resuscitator) Anesthesiology Class 2 868.5915 2017-01-13
EOQ Bronchoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4680 2018-04-05
IKD Cable, Electrode Physical Medicine Class 2 890.1175 2010-11-26
EOQ Bronchoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4680 2021-06-17
GXY Electrode, Cutaneous Neurology Class 2 882.1320 2009-12-09
FAJ Cystoscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2016-08-19
EOQ Bronchoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4680 2022-07-25
BSJ Mask, Gas, Anesthetic Anesthesiology Class 1 868.5550 2005-03-28
FAJ Cystoscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2025-06-12
EOQ Bronchoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4680 2023-06-02
GXY Electrode, Cutaneous Neurology Class 2 882.1320 2007-12-27
BTM Ventilator, Emergency, Manual (Resuscitator) Anesthesiology Class 2 868.5915 2009-12-09
CBI Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector) Anesthesiology Class 2 868.5740 2021-05-21
OGH Laryngoscope Kit Anesthesiology Class 1 868.5540 2025-11-20
BTM Ventilator, Emergency, Manual (Resuscitator) Anesthesiology Class 2 868.5915 2009-12-09
FDT Duodenoscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2024-04-18
FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2024-04-18
IQK Orthosis, Cervical Physical Medicine Class 1 890.3490 2005-03-28
FAJ Cystoscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2020-04-03
EOQ Bronchoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4680 2019-07-13
EOB Nasopharyngoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4760 2019-07-13
FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2024-08-19
FGB Ureteroscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2024-08-19
CAP Monitor, Airway Pressure (Includes Gauge And/Or Alarm) Anesthesiology Class 2 868.2600 2008-02-05
OEV Cardiopulmonary Resuscitation Aid Kit Anesthesiology Class 2 868.5915 2024-01-09
IKT Electrode, Needle, Diagnostic Electromyograph Physical Medicine Class 2 890.1385 2010-04-29
EOB Nasopharyngoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4760 2019-05-23
EOQ Bronchoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4680 2019-05-23
FAJ Cystoscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2024-10-22
FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2024-10-22
BYG Mask, Oxygen Anesthesiology Class 1 868.5580 2006-12-22
GXZ Electrode, Needle Neurology Class 2 882.1350 2009-12-09
IKT Electrode, Needle, Diagnostic Electromyograph Physical Medicine Class 2 890.1385 2009-12-09
BYE Attachment, Breathing, Positive End Expiratory Pressure Anesthesiology Class 2 868.5965 2015-09-18
FAJ Cystoscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2024-10-22
FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2024-10-22
CAE Airway, Oropharyngeal, Anesthesiology Anesthesiology Class 1 868.5110 2003-12-08
DRX Electrode, Electrocardiograph Cardiovascular Class 2 870.2360 2013-05-06
FMH Container, Specimen, Sterile Pathology Class 1 864.3250 2019-01-10
GXY Electrode, Cutaneous Neurology Class 2 882.1320 2009-12-09
EOQ Bronchoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4680 2023-08-11
EOQ Bronchoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4680 2023-01-17
FEM Accessories, Photographic, For Endoscope (Exclude Light Sources) Gastroenterology, Urology Class 1 876.1500 2020-05-01
GXY Electrode, Cutaneous Neurology Class 2 882.1320 2009-12-09

Official Correspondent

No official correspondent registered.

US Agent Details

Sanjay Parikh Business: Ambu Inc Email: SAP@ambu.com Phone: (410) 7686464

Related Public Records

Same Entity

AMBU A/S
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3003924186 AMBU Limited XIANG YU F.T.Z., XIAMEN Fujian, CN
3022631687 Ambu Mexico Operations S.A. DE C.V. Ciudad Juarez Chihuahua, MX
3004040397 AMBU SDN.BHD. PENANG Pulau Pinang, MY

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K843874 Beiersdorf, Inc. LEUKOPOR SURGICAL TAPE 1985-02-21
K915446 Sun Glitz Corp. STRETCH WRAP 1992-05-06
K833120 Acme United Corp. ONE TIME COMPOUND BENZOIN TINCTURE- 1983-12-29
K870091 Avery Intl. IV SECUREMENT DEVICE USING PCCE THERMO. FILM 1987-02-04
K070612 Top-Rank Health Care Equipment Co., Ltd. TOP-RANK ADHESIVE ELECTRODE 2007-05-07

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0144-2024 Covidien 1
Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000
Z-0168-2024 Covidien 1
McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-017-000, Sterile EO, Rx Only
Z-0169-2024 Covidien 1
McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-084-000, Sterile EO, Rx Only
Z-0039-2010 Unomedical 2
Infant Manual Pulmonary Resuscitator with reservoir bag, face mask & Gas sampling elbow. Product ID # 5801, 12-8713, 732-E, and 2206. Packaged under the name of Dynarex, Evergreen, Mada and Hospitak. Recalled codes may be identified by examining the patient valve housing immediately below the right-angle exhalation port, where the retention ring should be visible. MPR units with a clear or transparent ring, as well as those where no ring can be seen, should be returned. MPR units with a blue retention ring are not affected and do not need to be returned.
Z-0040-2010 Unomedical 2
Pediatric Manual Pulmonary Resuscitator with reservoir bag, face mask & Gas sampling elbow. Product ID #s: 5804; 12-8709, 727-E; 727MM, 2203. Packaged under the name of Dynarex, Evergreen, Mada and Hospitak.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9610691. Last updated year: 2026. Please use registration number 9610691 when referencing this establishment in official correspondence.
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