HomeChinaAmbu

Ambu

China · 上海
✓ Record-verifiedregistrations found in 6 marketsUnified social credit code 913502006712577710

This company has registrations in United States, Brazil, Canada, Taiwan, South Korea, Australia — 6 overseas markets. No China NMPA registrations were found.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
0China registrations
as of 2026-09-01
EUEuropean UnionEUDAMED
0UDI-DI device records
USUnited StatesFDA openFDA
25listed device types
Class I 9Class II 16Class III 0
plus 46 registration records and 33 510(k)
UKUnited KingdomMHRA PARD
0registered device records
BRBrazilANVISA
1registered devices
Class II 1
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
1active device licences
Class II 1
TWTaiwanTFDA
10valid device licences
Class I 4Class II 6
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
6GMP quality-system certificates
Import 6
AUAustraliaTGA ARTG
39active ARTG entries
Class I 13IIa 16IIb 9Class Is (sterile) 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
pendingnot queried
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.

European Union564 raw hits, 300 excluded, 0 confirmed. Large result set — only the first 300 verified
United States46 registration records, 33 510(k), 0 PMA, 5 excluded
China0 certificates (Class III 0 / II 0 / I 0), as of 2026-09-01
United Kingdom0 confirmed, 2 excluded
Brazil1 confirmed, 1 excluded
Canada1 confirmed, 1 excluded
Manufacturer names merged into this page: AMBU SDN.BHD. · AMBU Limited · AMBU INC · AMBU LTD

Regulatory identity

Unified social credit code
913502006712577710
Exhibition record
CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Company information

Country
China
Social-insurance enrolees
47
Annual revenue
RMB 30–50M
Product categories
呼吸、麻醉和急救器械医用成像器械医用诊察和监护器械

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

Business registration

Registration status
Active
Incorporated
2008-04-15
Registered capital
USD 1,350,000
Paid-in capital
USD 1,350,000
Legal form
Limited liability company (wholly owned by a foreign corporation)
Industry classification
Wholesale trade
Last approval date
2025-09-25
Recognitions
Micro and small enterprise

Business registration data from Tianyancha, as of 2026-09-02. Public registry information only; legal representative and contact-person details are not collected. The figure is the number of employees enrolled in social insurance as declared by the company, which may differ from actual headcount.

FDA 510(k) clearances by year

21984
11985
11987
21988
21990
31991
41992
31993
11995
11997
11998
21999
12000
12001
72004
12005

FDA listed device types

showing 8 of 25
Electrode, Needle 1Nasopharyngoscope (Flexible Or Rigid) 1Bronchoscope (Flexible Or Rigid) 1Cystoscope And Accessories, Flexible/Rigid 1Cardiopulmonary Resuscitation Aid Kit 1Monitor, Airway Pressure (Includes Gauge And/Or Alarm) 1Electrode, Cutaneous 1Electrode, Electrocardiograph 1

Registration details (sample)

MarketIdentifierNameClass / date
USK051529AMBU NEUROLINE GROUND2005-08-04
USK042682AMBU SPUR II. ADULT SINGLE PATIENT RESUSCITATOR2004-11-15
USK042843AMBU SPUR II INFANT AND PEDIATRIC SINGLE PATIENT USE RESUSCITATORS2004-11-12
BR80047300725Ressuscitador de Silicone Oval Ambu®Class II
CA6914AMBU OXYGEN REGULATORClass II

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