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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 10 of 26
DeviceModel / ReferenceRegistriesClassStatus
Neuroline CupNeurology Surface Electrode 72620-M-CM-10
FDA UDI
Class IIUnknown
BlueSensor NECG Electrodes N-10-F/25
FDA UDI
Class IIActive
Ambu® SPUR® II Pediatric Resuscitator 530613000
FDA UDI
Class IIActive
SPUR® II Pediatric ResuscitatorSingle Patient Use Resuscitator 531615000
FDA UDI
Class IIActive
Catheter Set, 190mm Cut-to Size 418000503
FDA UDI
Class IIActive
SPUR® II Infant ResuscitatorSingle Patient Use Resuscitator 544216047
FDA UDI
Class IIActive
SleepmateBeltless Effort Sensor, Infant/Pediatric 813065-100
FDA UDI
Class IIActive
Neuroline 720Neurology Surface Electrodes 72015-K/C/12
FDA UDI
Class IIActive
SmartInfuser Set, 1-6ml/hr, with MultiBolus + Y-Tubing Set 418000512
FDA UDI
Class IIActive
Ambu® SureSight® Blade 390331000
FDA UDI
Class IActive
ECG Electrodes 0315M/LYNN
FDA UDI
Class IIUnknown
Skin Prep PadAbrasive Pad for Skin Preparation 2121M
FDA UDI
Class IIUnknown
SleepmateRIPmate Cable 819150-000
FDA UDI
Class IIActive
SPUR® II Infant ResuscitatorSingle Patient Use Resuscitator 544211000B
FDA UDI
Class IIUnknown
Aura40 326100000U
FDA UDI
Class IActive
SPUR® II Infant ResuscitatorSingle Patient Use Resuscitator 540200000
FDA UDI
Class IIActive
AuraFlex 327500000U
FDA UDI
Class IActive
SPUR® II Adult Resuscitator 523611030E
FDA UDI
Class IIActive
aScope™ 5 Broncho HD 5.0/2.2 621001000US
FDA UDI
Class IIActive
Ambu® ACTion™ Fuser Pump 418103200M
FDA UDI
Class IIActive
SPUR® II Pediatric Resuscitatorw/Expiratory Filter 30MM & Manometer 530613017
FDA UDI
Class IIActive
SPUR® II Pediatric Resuscitator 530613073
FDA UDI
Class IIActive
BlueSensor QECG Electrodes Q-100-K/10
FDA UDI
Class IIUnknown
Ambu® ACTion™ Fuser Pump 418108400M
FDA UDI
Class IIActive
Concentric Kit 740-US/SET
FDA UDI
Class IIActive
SPUR® II Pediatric ResuscitatorSingle Patient Use Resuscitator 530233000
FDA UDI
Class IIActive
aScope™ Duodeno 482001000/4
FDA UDI
Class IIActive
SleepmateRIPmate Inductance Kit, Infant 819101-100
FDA UDI
Class IIUnknown
Ambu® SPUR® II Pediatric Resuscitator 530613073
FDA UDI
Class IIActive
Ambu WhiteSensor 4500M-H 4500M-H/5
FDA UDI
Class IIUnknown
SleepmateInductance Belt Thorax Kit, Adult - Alice 5 819003-121
FDA UDI
Class IIActive
Ambu® ACTion™ Block Pump 418201200C
FDA UDI
Class IIActive
Reusable PEEP 20 valve A000213000
FDA UDI
Class IIActive
Neuroline 700 70015-M/12
FDA UDI
Class IIActive
Ambu Neuroline Concentric Cable, Lenght of leadwire: 100 cm (39") 1741
FDA UDI
Class IIActive
SPUR® II Adult ResuscitatorSingle Patient Use Resuscitator 520214000
FDA UDI
Class IIActive
Ambu® SPUR® II Adult Resuscitator 521611049
FDA UDI
Class IIActive
Ambu® SPUR® II Pediatric Resuscitator 531600000
FDA UDI
Class IIActive
SleepmatePiezo Film Sensor & Band, Adult, Double Loop 813213-100
FDA UDI
Class IIActive
Ambu® SPUR® II Pediatric Resuscitator 530613831
FDA UDI
Class IIActive
ACTion Fuser Pump, 650ml, 5-15 ml/hrDual 190mm caut-to-size catheter 418106650
FDA UDI
Class IIActive
BlueSensor NFECG Electrodes NF-50-K/3/US
FDA UDI
Class IIActive
4" introducerStand alone, complementary accessory (to be used with ACT 418000536
FDA UDI
Class IIActive
Ambu® ACTion™ Block Pump 418201400C
FDA UDI
Class IIActive
aScope™ Colon 484001000US
FDA UDI
Class IIActive
aScope™ 4 RhinoLaryngo Intervention 512001000
FDA UDI
Class IIActive
TubeChek-B 000172002
FDA UDI
Class IIUnknown
Ambu® SPUR® II Adult Resuscitator 523611001
FDA UDI
Class IIActive
Neuroline 700 70010-M/12
FDA UDI
Class IIActive
Ambu® SPUR® II Pediatric Resuscitator 531614030
FDA UDI
Class IIActive

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