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Ambu A/S

US

Last updated May 24, 2026

Information

Country
US
Address
—
Website
ambuusa.com
LinkedIn
—
Facebook
—
Email
[email protected]
Phone
+14107686464
PRRC Contact
—
EUDAMED SRN
—
FDA FEI Number
—
DUNS Number
305682023

Catalogue (1294)

Page 26 of 26
DeviceModel / ReferenceRegistriesClassStatus
9021s0235 71002-SC/AP/12
FDA UDI
Class IIActive
SleepmateAC Body Position Sensor 815600-000
FDA UDI
Class IIActive
Ambu WhiteSensor 4535MECG Electrodes 4535M
FDA UDI
Class IIUnknown
SleepmateThermal AirFlow Sensor, Medium / Pediatric 814302-000/20
FDA UDI
Class IIActive
aScope™ 4 RhinoLaryngo Intervention 512101000
FDA UDI
Class IIActive
Ambu Subdermal CorkscrewSingle Patient Probes 74720-60/24
FDA UDI
Class IIActive
Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Reverse Deflection); Ambu® aBox™ 2 K240849
FDA 510(k)
Class IIActive
Ambu Blue Sensor Neo And Neo X K053550
FDA 510(k)
Class IIActive
Ambu® aScope™ 5 Uretero (Standard Deflection); Ambu® aScope™ 5 Uretero (Reverse Deflection); Ambu® aView™ 2 Advance K242108
FDA 510(k)
Class IIActive
Ambu Ascope 3 5.0/2.2; Ambu Ascope 3 Slim 3.8/1.2; Ambu Aview K130845
FDA 510(k)
Class IIActive
Ambu aScope 4 RhinoLaryngo Intervention K190972
FDA 510(k)
Class IIActive
Ambu aScope 5 Broncho HD 5.6/2.8, Ambu aScope 5 Broncho HD 5.0/2.2, Ambu aBox 2 K220606
FDA 510(k)
Class IIActive
Ambu® aScope™ 5 Uretero (Standard Deflection); Ambu® aScope™ 5 Uretero (Reverse Deflection); Ambu® aBox™ 2 K233630
FDA 510(k)
Class IIActive
Ambu Ascope And Monitor K093186
FDA 510(k)
Class IIActive
Modification To: Ambu Neuroline Concentric Needle Electrode K071186
FDA 510(k)
Class IIActive
Ambu Ascope 2 K110962
FDA 510(k)
Class IIActive
Ambu Mark Iv Baby Resuscitator K053142
FDA 510(k)
Class IIActive
Ambu aScope RLS Slim K181286
FDA 510(k)
Class IIActive
Ambu Blue Sensor Neo, Ambu Blue Sensor Neo X K100129
FDA 510(k)
Class IIActive
Ambu USR, Ambu M K160766
FDA 510(k)
Class IIActive
Ambu Mark Iv Resuscitator K053140
FDA 510(k)
Class IIActive
Ambu® aScope™ 5 Broncho 4.2/2.2; Ambu® aScope™ 5 Broncho 2.7/1.2; Ambu® aView™ 2 Advance K233671
FDA 510(k)
Class IIActive
Ambu aScope 4 Cysto K193095
FDA 510(k)
Class IIActive
Ambu® Virobac II® Exhalation Filter K251583
FDA 510(k)
Class IIActive
Ambu® aScope™ Duodeno 2, Ambu® aBox™ 2 K233886
FDA 510(k)
Class IIActive
Ambu® aScope™ Gastro, Ambu® aBox™2 K212382
FDA 510(k)
Class IIActive
Ambu® aScope™ 5 Broncho HD 5.0/2.2, Ambu® aScope™ 5 Broncho HD 5.6/2.8, Ambu® aView™ 2 Advance K223299
FDA 510(k)
Class IIActive
Ambu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric Resuscitator, Ambu SPUR II Infant Resuscitator K152931
FDA 510(k)
Class IIActive
Ambu Neuroline Disposable Inoject Needle Electrode K093825
FDA 510(k)
Class IIActive
Ambu® aScope™ Gastro Large; Ambu® aBox™ 2 K232919
FDA 510(k)
Class IIActive
Ambu® aScope™ Colon; Ambu® aBox™ 2 K230332
FDA 510(k)
Class IIActive
Ambu Oval Silicone Resuscitator, Adult And Pediatric K102824
FDA 510(k)
Class IIActive
Ambu® aScope™ 5 Broncho 2.7/1.2, Ambu® aScope™ 5 Broncho 4.2/2.2, Ambu® aBox™ 2 K230428
FDA 510(k)
Class IIActive
Ambu VivaSight 2 DLT, Ambu VivaSight 2 Adapter Cable K203749
FDA 510(k)
Class IIActive
Ambu aScope 3 Regular 5.0/2.2, Ambu aScope 3 Slim 3.8/1.2, Ambu aScope 3 Large 5.8/2.8, Ambu aView Monitor K161656
FDA 510(k)
Class IIActive
Ambu aScope 3 Slim 3.8/1.2 and Ambu aScope 4 Broncho Slim 3.8/1.2; Ambu aScope 3 Regular 5.0/2.2 and Ambu aScope 4 Broncho Regular 5.0/2.2; Ambu aScope 3 Large 5.8/2.8 and Ambu aScope 4 Broncho Large 5.8/2.8; Ambu aView Monitor K173727
FDA 510(k)
Class IIActive
Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Reverse Deflection); Ambu® aView™ 2 Advance K240848
EUDAMEDFDA 510(k)
Class IIActive
Ambu aScope 4 RhinoLaryngo Slim K191080
FDA 510(k)
Class IIActive
Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Reverse Deflection) K250269
FDA 510(k)
Class IIActive
aScope 4 Broncho Regular Sampler Set 5.0/2.2, aScope 4 Broncho Large Sampler Set 5.8/2.8 K210883
FDA 510(k)
Class IIActive
Ambu® aScope™ 5 Broncho 4.2/2.2 Sampler Set K232582
FDA 510(k)
Class IIActive
Modification To: Ambu Neuroline, Disposable Monopolar Needle Electrode K071185
FDA 510(k)
Class IIActive
Ambu White Sensor Cfm, Cfl K052944
FDA 510(k)
Class IIActive
Ambu aScope 5 Broncho HD 5.6/2.8 Sampler Set, Ambu aScope 5 Broncho HD 5.0/2.2 Sampler Set K223782
FDA 510(k)
Class IIActive

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