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Ambu A/S

US

Last updated May 24, 2026

Information

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

Catalogue (1294)

Page 7 of 26
DeviceModel / ReferenceRegistriesClassStatus
Ambu WhiteSensor 4500M-HECG Electrodes 4500M-H/10
FDA UDI
Class IIUnknown
SleepmateCannuTherm, - Alice 5 814310-121
FDA UDI
Class IIUnknown
Ambu® SPUR® II Adult Resuscitator 523611030E
FDA UDI
Class IIActive
Ambu aView™ 2 Advance 405011000
FDA UDI
Class IActive
SPUR® II Adult ResuscitatorSingle Patient Use Resuscitator 523611001
FDA UDI
Class IIActive
Ambu® SPUR® II Pediatric Resuscitator 531613000
FDA UDI
Class IIActive
AuraGain 408500000
FDA UDI
Class IActive
Ambu® SPUR® II Adult Resuscitator 520611033AF
FDA UDI
Class IIActive
Neuroline CupNeurology Surface Electrodes 72620-M/10
FDA UDI
Class IIActive
Ambu® SPUR® II Adult Resuscitator 521611700
FDA UDI
Class IIActive
SmartInfuser Set, 5-15ml/hr, with MultiBolus + Y-Tubing Set 418000520
FDA UDI
Class IIActive
Neuroline CupNeurology Surface Electrode 72610-M-CM-10
FDA UDI
Class IIUnknown
Ambu® SPUR® II Adult Resuscitator 520211011
FDA UDI
Class IIActive
SPUR® Infant Resuscitator 544216051
FDA UDI
Class IIActive
SPUR® II Adult ResuscitatorSingle Patient Use Resuscitator 523211001
FDA UDI
Class IIActive
Ambu® SPUR® II Adult Resuscitator 520211033
FDA UDI
Class IIActive
Ambu® SPUR® II Adult Resuscitator 524611011
FDA UDI
Class IIActive
SPUR® II Infant Resuscitatorw/PEEP Valve 20 and extra 10' tubing 540212064
FDA UDI
Class IIActive
BlueSensor NFECG Electrodes NF-00-S/12
FDA UDI
Class IIActive
Ambu® SPUR® II Pediatric Resuscitator 530214000
FDA UDI
Class IIActive
SPUR® II Pediatric ResuscitatorSingle Patient Use Resuscitator 531613055
FDA UDI
Class IIActive
Perfit Collar™ 000264203
FDA UDI
Class IActive
BlueSensor QECG Electrodes Q-10-F/25
FDA UDI
Class IIUnknown
SleepmateSoft Loop Bands 813000-100
FDA UDI
Class IIUnknown
Ambu® SPUR® II Pediatric Resuscitator 530612010
FDA UDI
Class IIActive
Reusable PEEP 10 valve A000138000
FDA UDI
Class IIActive
Ambu WhiteSensor 4500M-HECG Electrodes 4500M-H
FDA UDI
Class IIUnknown
SPUR® II Adult Resuscitator 520611074
FDA UDI
Class IIActive
SleepmateSnore Sensor - 60 cm wire 812210-000
FDA UDI
Class IIActive
SPUR® II Pediatric ResuscitatorSingle Patient Use Resuscitator 531600001
FDA UDI
Class IIUnknown
SPUR® II Adult Resuscitatorw/Nellcor CO2 Detector 520611700N
FDA UDI
Class IIUnknown
BlueSensor VLCECG Electrodes VLC-00-S/4
FDA UDI
Class IIActive
AuraStraight 324100000U
FDA UDI
Class IActive
Snore Microphone 60cm-CadwellSleepmate 202790-000-024
FDA UDI
Class IIActive
Ambu® SPUR® II Adult Resuscitator 520611010
FDA UDI
Class IIActive
SPUR® II Pediatric Resuscitatorw/CO2 Detector 530612800N
FDA UDI
Class IIUnknown
BlueSensor BRECG Electrodes BR-80-K/12
FDA UDI
Class IIActive
Catheter Set, 140mm Cut-to Size, 6" Introducer 418000502
FDA UDI
Class IIActive
Mark IV Baby Resuscitator 299007000
FDA UDI
Class IIActive
Ambu® ACTion™ Fuser Pump 418103200C
FDA UDI
Class IIActive
SPUR® II Pediatric ResuscitatorSingle Patient Use Resuscitator 531611000
FDA UDI
Class IIActive
Ambu WhiteSensor 5050 5050-00-S/5
FDA UDI
Class IIUnknown
aScope BronchoSampler™Specimen Sampling System - Single Use 480200000
FDA UDI
Class IIUnknown
SPUR® II Pediatric ResuscitatorSingle Patient Use Resuscitator 531613001
FDA UDI
Class IIActive
Ambu® ACTion™ Block Pump 4191511000C
FDA UDI
Class IIActive
Neuroline 700 70010-M/C/12
FDA UDI
Class IIActive
Neuroline Twisted Pair SubdermalNeurology Needle Electrodes 74612-200/2/20
FDA UDI
Class IIActive
SPUR® II Infant ResuscitatorSingle Patient Use Resuscitator 540211030
FDA UDI
Class IIActive
AuraFlex 327400000U
FDA UDI
Class IActive
Res-Cue Key Face Shield 248201104
FDA UDI
Class IIActive

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