HomeChinaGaleMed (Xiamen) Co., Ltd.

GaleMed (Xiamen) Co., Ltd.

China · Xiamen
✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Canada, South Korea, Australia, Israel — 6 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
pendingnot queried
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
33listed device types
Class I 19Class II 14Class III 0
plus 52 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
14registered devices
Class II 14
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
0active device licences
28 including historic records
TWTaiwanTFDA
0valid device licences
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
3GMP quality-system certificates
Import 3
AUAustraliaTGA ARTG
42active ARTG entries
Class I 2IIa 24IIb 16
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
1registrations
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.

United States52 registration records, 0 510(k), 0 PMA, 3 excluded
Brazil14 confirmed, 1 excluded
Canada0 confirmed, 1 excluded
Manufacturer names merged into this page: GaleMed (Xiamen) Co., Ltd. · GALEMED (XIAMEN) CO., LTD. · GALEMED XIEMEN CO., LTD.

Company information

Country
China
City
Xiamen

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.

FDA listed device types

showing 8 of 33
Filter, Bacterial, Breathing-Circuit 1Spirometer, Monitoring (W/Wo Alarm) 1Ventilator, Non-Continuous (Respirator) 1Cardiopulmonary Resuscitation Aid Kit 1Monitor, Airway Pressure (Includes Gauge And/Or Alarm) 1Nebulizer (Direct Patient Interface) 1Attachment, Breathing, Positive End Expiratory Pressure 1Resuscitator, Manual, Non Self-Inflating 1

Registration details (sample)

MarketIdentifierNameClass / date
BR80301139014CÂMARA DE UMIDIFICAÇÃO HUMI.AIDEClass II
BR80301139015VALVULA BUBBLE PAPClass II
BR80301139016PLS VALVEClass II

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