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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 24 of 26
DeviceModel / ReferenceRegistriesClassStatus
Ambu® ACTion™ Block Pump 419109650C
FDA UDI
Class IIActive
Neuroline 700 70002-M/12
FDA UDI
Class IIActive
BlueSensor TECG Electrodes T-00-S/25
FDA UDI
Class IIActive
AuraStraight 324500000U
FDA UDI
Class IActive
SPUR® II Pediatric Resuscitatorw/CO2 Detector & Manometer 531613830
FDA UDI
Class IIActive
SPUR® II Adult ResuscitatorSingle Patient Use Resuscitator 520211071
FDA UDI
Class IIActive
Neuroline MonopolarNeurology Needle Electrodes 74338-36/40
FDA UDI
Class IIActive
BlueSensor LECG Electrodes L-00-S/25
FDA UDI
Class IIActive
Silicone Face Mask 000312000
FDA UDI
Class IActive
SPUR® II Infant ResuscitatorSingle Patient Use Resuscitator 544216001
FDA UDI
Class IIActive
SleepmateThermistor - Alice 5 814910-121
FDA UDI
Class IIActive
King Mask 2045
FDA UDI
Class IActive
SPUR® II Adult ResuscitatorSingle Patient Use Resuscitator 523631011
FDA UDI
Class IIActive
SleepmateOral / Nasal wo. Filter 814310-000/50
FDA UDI
Class IIActive
Oval Silicone ResuscitatorPediatric 370001000
FDA UDI
Class IIUnknown
Ambu® SureSight® Blade 390221000
FDA UDI
Class IActive
ACTion Fuser Pump, 650ml, 5-15 ml/hrDual 140mm caut-to-size catheter 418109650
FDA UDI
Class IIActive
Neuroline Twisted Pair SubdermalNeurology Needle Electrodes 74612-100/2/20
FDA UDI
Class IIActive
aScope™ Gastro 483001000US
FDA UDI
Class IIActive
SPUR® II Infant ResuscitatorSingle Patient Use Resuscitator 540216031
FDA UDI
Class IIActive
SPUR® II Pediatric ResuscitatorSingle Patient Use Resuscitator 530615031
FDA UDI
Class IIActive
SPUR® II Adult ResuscitatorSingle Patient Use Resuscitator 521600000
FDA UDI
Class IIActive
Ambu WhiteSensor 4440 4440/5
FDA UDI
Class IIUnknown
SPUR® II INFANT TUBE RESVR.w/Manometer & C02 Detector 544212830
FDA UDI
Class IIActive
AuraOnce 321500000U
FDA UDI
Class IActive
aScope™ 3 Regular 5.0/2.2Flexible Videoscope - Single Use 403001000
FDA UDI
Class IIUnknown
BlueSensor MECG Electrodes M-00-F/50
FDA UDI
Class IIActive
Mark IV Resuscitatorwith single shutter patient valve 304003000
FDA UDI
Class IIActive
SPUR® II Adult ResuscitatorSingle Patient Use Resuscitator 523211000
FDA UDI
Class IIActive
Neuroline 710Neurology Surface Electrodes 71002-SC/12
FDA UDI
Class IIActive
SPUR® II Pediatric ResuscitatorSingle Patient Use Resuscitator 530613071
FDA UDI
Class IIActive
SleepmateRIPmate Kit - Integrated RIP Keyhole 819100-108
FDA UDI
Class IIActive
SPUR® II Infant ResuscitatorSingle Patient Use Resuscitator 544212017
FDA UDI
Class IIActive
Ambu WhiteSensor WSP30 WSP30-00-S/50
FDA UDI
Class IIUnknown
BLUE MAXMortara Instrument R-00-S/BUR/25
FDA UDI
Class IIUnknown
SPUR® II Pediatric ResuscitatorSingle Patient Use Resuscitator 530639011
FDA UDI
Class IIActive
Catheter Set, 140mm Cut-to Size, 6" Introducer + Flowsplitter 418000504
FDA UDI
Class IIActive
SPUR® II Pediatric ResuscitatorSingle Patient Use Resuscitator 530613011
FDA UDI
Class IIActive
Ambu WhiteSensor 4570MECG Electrodes 4570M
FDA UDI
Class IIUnknown
Neuroline GroundNeurology Surface Electrodes 71415-M/1
FDA UDI
Class IIActive
Mark IV Resuscitatorwith single shutter patient valve 304006000
FDA UDI
Class IIActive
Neuroline 700Neurology Surface Electrodes 70001-K/12
FDA UDI
Class IIUnknown
King Mask 1433
FDA UDI
Class IActive
SPUR® II Infant ResuscitatorSingle Patient Use Resuscitator 544216010
FDA UDI
Class IIActive
Oval Silicone Resuscitator, Neonate A288001000
FDA UDI
Class IIUnknown
Ambu WhiteSensor 5050 5050-00-S/3
FDA UDI
Class IIUnknown
BlueSensor VLECG Electrodes VL-50-K/25
FDA UDI
Class IIUnknown
Mediwatch PlcNeurology Surface Electrodes 71002-SC/MW/12
FDA UDI
Class IIUnknown
SPUR® II Infant ResuscitatorSingle Patient Use Resuscitator 540211001
FDA UDI
Class IIActive
Neuroline Cup 72615-M/25
FDA UDI
Class IIActive

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