Ambu A/S

Denmark · Ballerup

✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, Hong Kong, Israel, Russia — 8 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

27listed device types

Class I 10Class II 17Class III 0

plus 48 registration records and 39 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

27registered devices

Class I 6Class II 21

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

27active device licences

Class II 27

55 including historic records

TWTaiwanTFDA

13valid device licences

Class I 5Class II 8

SGSingaporeHSA SMDR

21device registrations

CLASS B 21

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

14valid listings

Class II 14

ILIsraelAMAR

33registrations

RURussiaRoszdravnadzor

5active registrations

Class 1 2Class 2a 3

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States48 registration records, 39 510(k), 0 PMA, 6 excluded

Brazil27 confirmed, 1 excluded

Canada27 confirmed, 1 excluded

Manufacturer names merged into this page: Ambu A/S · AMBU A/S

FDA 510(k) clearances by year

22005

22006

22007

32010

22011

12013

32016

22018

22019

12020

22021

22022

52023

72024

12025

22026

FDA listed device types

showing 8 of 27

Electrode, Needle 1Nasopharyngoscope (Flexible Or Rigid) 1Bronchoscope (Flexible Or Rigid) 1Cystoscope And Accessories, Flexible/Rigid 1Cable, Electrode 1Cardiopulmonary Resuscitation Aid Kit 1Monitor, Airway Pressure (Includes Gauge And/Or Alarm) 1Electrode, Cutaneous 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K260578	Ambu® NeurolineTM Cup MRI/CT (Models 72704/21US, 72704/23US, 72704/25US, 72704/27US) Ambu® NeurolineTM Cup MRI/CT-set (Models 72704/21-1010US, 72704/21-1010US, 72704/23-1010US, 72704/25-1010US, 72704/27-1010US) Ambu® NeurolineTM Cup MRI/CT-mini set (Models 72704/21-0301US, 72704/23-0301US, 72704/25-0301US, 72704/27-0301US)	2026-07-14
US	K251583	Ambu® Virobac II® Exhalation Filter	2026-04-30
US	K250269	Ambu® aScope 5 Cysto HD (Standard Deflection); Ambu® aScope 5 Cysto HD (Reverse Deflection)	2025-06-11
BR	80047309184	aScope 4 RhinoLaryngo Intervention	Class II
BR	80047309186	aScope 4 RhinoLaryngo Slim	Class II
BR	80047300716	AMBU® NEUROLINE MONOPOLAR	Class II
CA	6783	VACUUM MATTRESS, STRETCHER/TRANSFER MATTRESS	Class II
CA	366	AMBU MEDIBAG (ADULT, INFANT/CHILD)	Class II
CA	6829	UNISUCTION PUMP & SUCTION BOOSTER	Class II

Ambu A/S

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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