Is this your brand? Sign in to claim ownership.

Sign in to claim this brand

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 11 of 26
DeviceModel / ReferenceRegistriesClassStatus
SPUR® II Pediatric Resuscitatorw/CO2 Detector 530614800
FDA UDI
Class IIActive
Ambu® SPUR® II Pediatric Resuscitator 531600051
FDA UDI
Class IIActive
Ambu® Mark IV 299004000
FDA UDI
Class IIActive
Ambu® SPUR® II Pediatric Resuscitator 531612000
FDA UDI
Class IIActive
SleepmateCannuTherm Thermocouple - 90 cm 814850-100
FDA UDI
Class IIActive
aScope™ 4 RhinoLaryngo Slim 510101000
FDA UDI
Class IIActive
Mark IV Resuscitatorwith single shutter patient valve 304009000
FDA UDI
Class IIActive
SPUR® II Pediatric ResuscitatorSingle Patient Use Resuscitator 530613025
FDA UDI
Class IIActive
Disposable Face Masks 000252055
FDA UDI
Class IActive
6" introducerStand alone, complementary accessory (to be used with ACT 418000537
FDA UDI
Class IIActive
Redi-ACE - Adult 472003000
FDA UDI
Class IActive
Ambu® SureSight® Blade 390101000
FDA UDI
Class IActive
SPUR® II Adult ResuscitatorSingle Patient Use Resuscitator 520211038
FDA UDI
Class IIActive
SPUR® II Pediatric Resuscitatorw/CO2 Detector & Manometer 530613830
FDA UDI
Class IIActive
Ambu WhiteSensor 0715M BIOTABSECG Electrodes 0715M
FDA UDI
Class IIUnknown
SPUR® Adult Resuscitator 520611748
FDA UDI
Class IIActive
Neuroline 725Neurology Surface Electrodes 72501-SC/12
FDA UDI
Class IIUnknown
Ambu® SPUR® II Adult Resuscitator 524611000
FDA UDI
Class IIActive
Y-Tubing - Splitter 418000507
FDA UDI
Class IIActive
Ambu® ACTion™ Fuser Pump 418113400C
FDA UDI
Class IIActive
Rdic-Butyl ResuscitatorFace Mask, Canister Filter and 233005000
FDA UDI
Class IIActive
Res-Cue Key WorldPoint3 blue Soft WP-203
FDA UDI
Class IIUnknown
BlueSensor BRECG Electrodes BR-50-K/3
FDA UDI
Class IIUnknown
SPUR® II Pediatric ResuscitatorSingle Patient Use Resuscitator 530214000B
FDA UDI
Class IIActive
Ambu® SPUR® II Adult Resuscitator 520611000
FDA UDI
Class IIActive
ACTion Fuser Pump, 650ml, 5-15 ml/hrMultiBolus, 140mm caut-to-size cat 418102650
FDA UDI
Class IIActive
Ambu® SPUR® II Pediatric Resuscitator 530613057
FDA UDI
Class IIActive
SPUR® II Pediatric ResuscitatorSingle Patient Use Resuscitator 530613034
FDA UDI
Class IIActive
SPUR® II Pediatric ResuscitatorSingle Patient Use Resuscitator 531614000
FDA UDI
Class IIActive
Ambu® Disposable Pressure Manometer 322004000
FDA UDI
Class IIActive
SleepmatePressure AirFlow Kit - Alice 5 814300-121
FDA UDI
Class IIActive
Disposable Face Masks 000252054
FDA UDI
Class IActive
Oval Silicone ResuscitatorAdult, with pop off valve 470001100
FDA UDI
Class IIUnknown
Ambu® aScope™ Gastro Large 582101000
FDA UDI
Class IIActive
SleepmateRIPmate Locks for Disposable Bands 819211-000
FDA UDI
Class IIActive
SPUR® II Pediatric ResuscitatorSingle Patient Use Resuscitator 530600001
FDA UDI
Class IIActive
Ambu WhiteSensor 0415M BIOTABSECG Electrodes 0415M
FDA UDI
Class IIUnknown
aScope™ 3 Slim 3.8/1.2Flexible Videoscope - Single Use 402001000
FDA UDI
Class IIUnknown
SPUR® II Adult ResuscitatorSingle Patient Use Resuscitator 520212033
FDA UDI
Class IIActive
Neuroline 720Neurology Surface Electrodes 72020-K/C/12
FDA UDI
Class IIActive
BlueSensor BRECG Electrodes BR-80-A/12
FDA UDI
Class IIActive
Ambu® SPUR® II Pediatric Resuscitator 530212000B
FDA UDI
Class IIActive
SPUR® II Pediatric Resuscitator 530633051
FDA UDI
Class IIActive
VivaSight™ 2 DLT Kit 37 Fr - LEFT 412371000
FDA UDI
Class IIActive
AuraFlex 327600000U
FDA UDI
Class IActive
Oval Silicone ResuscitatorPediatric 370003000
FDA UDI
Class IIUnknown
BlueSensor NFECG Electrodes NF-50-A/12
FDA UDI
Class IIUnknown
Ambu® SureSight® Blade 390341000
FDA UDI
Class IActive
Ambu® SPUR® II Adult Resuscitator 523611057
FDA UDI
Class IIActive
SPUR® Pediatric Resuscitator 530213048
FDA UDI
Class IIActive

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.