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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 8 of 26
DeviceModel / ReferenceRegistriesClassStatus
SPUR® II Infant ResuscitatorSingle Patient Use Resuscitator 544200031
FDA UDI
Class IIActive
Neuroline SubdermalNeurology Needle Electrodes 74512-100/24
FDA UDI
Class IIActive
Ambu WhiteSensor 4500M-H 4500M-H/3
FDA UDI
Class IIUnknown
SleepmateNasal Cannula 814300-000/50
FDA UDI
Class IIActive
Res-Cue Key Face Shield 248201103
FDA UDI
Class IIActive
Ambu® aScope™ 5 Uretero 605101000
FDA UDI
Class IIActive
Disposable PEEP 20 valve 199003100
FDA UDI
Class IIActive
Ambu WhiteSensor 4831QECG Electrodes 4831Q
FDA UDI
Class IIUnknown
Ambu® SPUR® II Pediatric Resuscitator 530613031
FDA UDI
Class IIActive
Neuroline 700 70015-M/C/12
FDA UDI
Class IIActive
Ambu® Mark IV 299009000
FDA UDI
Class IIActive
Ambu® SPUR® II Adult Resuscitator 520211010
FDA UDI
Class IIActive
SPUR® II Infant ResuscitatorSingle Patient Use Resuscitator 544212031
FDA UDI
Class IIActive
Ambu® SPUR® II Adult Resuscitator 521600000
FDA UDI
Class IIActive
Isiris™ Monitor MN0001
FDA UDI
Class IIActive
Neuroline 715Neurology Surface Electrodes 71508-K/C/12
FDA UDI
Class IIActive
King Mask 1045
FDA UDI
Class IActive
SleepmateCannuTherm Thermistor - Alice 3 814320-119
FDA UDI
Class IIActive
SleepmateSnoring Piezo Sensor 812200-000
FDA UDI
Class IIActive
SPUR® II Pediatric ResuscitatorSingle Patient Use Resuscitator 530200031
FDA UDI
Class IIActive
Neuroline 700 70020-M/C/4
FDA UDI
Class IIActive
King Mask 1332
FDA UDI
Class IActive
SPUR® Infant Resuscitator 540212051
FDA UDI
Class IIActive
SPUR® II Pediatric ResuscitatorSingle Patient Use Resuscitator 531600027
FDA UDI
Class IIUnknown
BlueSensor RECG Electrodes R-00-S/7
FDA UDI
Class IIActive
Ambu WhiteSensor 4535M 4535M/3
FDA UDI
Class IIUnknown
SPUR® II Pediatric ResuscitatorSingle Patient Use Resuscitator 530213033
FDA UDI
Class IIActive
Res-Cue KeyFirst Responder Kit 3011042-000
FDA UDI
Class IIActive
SPUR® II Infant Resuscitatorw/Inspiratory Filter & Manometer 540212054
FDA UDI
Class IIActive
BlueSensor BRSECG Electrodes BRS-50-K/12
FDA UDI
Class IIActive
Ambu® SPUR® II Pediatric Resuscitator 530613830
FDA UDI
Class IIActive
Neuroline InojectNeurology Needle Electrodes 74438-45/10
FDA UDI
Class IIActive
aScope™ 4 Cysto 600005000
FDA UDI
Class IIActive
Ambu® SPUR® II Infant Resuscitator 544216069
FDA UDI
Class IIActive
SPUR® II Infant ResuscitatorSingle Patient Use Resuscitator 544216031
FDA UDI
Class IIActive
SPUR® II Adult Resuscitatorw/ Exhalation Filter 523616017
FDA UDI
Class IIActive
SPUR® II Adult Resuscitator 523211000E
FDA UDI
Class IIActive
SPUR® II Pediatric Resuscitator 531613071
FDA UDI
Class IIActive
BIOTABSECG Electrodes 0415M/SCHI
FDA UDI
Class IIUnknown
SleepmateRIPmate Kit with Disposable Bands - Keyhole 819200-108
FDA UDI
Class IIActive
SPUR® II Infant ResuscitatorSingle Patient Use Resuscitator 540211000
FDA UDI
Class IIActive
Viasys Qdc Cable Green 815000-031
FDA UDI
Class IIUnknown
SPUR® II Adult ResuscitatorSingle Patient Use Resuscitator 520611034
FDA UDI
Class IIActive
Ambu® SPUR® II Infant Resuscitator 544211000
FDA UDI
Class IIActive
SleepmateVelstretch Band Medium, Lt. Navy 813002-100
FDA UDI
Class IIActive
Disposable PEEP 20 valve 199003100
FDA UDI
Class IIUnknown
SPUR® II Adult ResuscitatorSingle Patient Use Resuscitator 520615000
FDA UDI
Class IIActive
SPUR® II Pediatric ResuscitatorINF&TOD W/MANOMETER 530615030
FDA UDI
Class IIActive
Isiris™ a ALFA01
FDA UDI
Class IIActive
Perfit Collar™ 000264201
FDA UDI
Class IActive

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