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Global Healthcare SG Sdn. Bhd

Malaysia · Negeri Sembilan
✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Australia — 2 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
14listed device types
Class I 1Class II 13Class III 0
plus 17 registration records and 4 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
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
TWTaiwanTFDA
0valid device licences
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
2active ARTG entries
Class I 2
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.

United States17 registration records, 4 510(k), 0 PMA, 9 excluded
Brazil0 confirmed, 3 excluded
Canada0 confirmed, 2 excluded
Manufacturer names merged into this page: SG HEALTHCARE CO LTD
Same-named companies — This database also contains companies with near-identical names: Sg Healthcare Co, Ltd.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
Malaysia
City
Negeri Sembilan

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 510(k) clearances by year

12015 · K150816
12022 · K222080
12023 · K230241
12025 · K240933

FDA listed device types

showing 8 of 14
Image-Intensified Fluoroscopic X-Ray System, Mobile 1Solid State X-Ray Imager (Flat Panel/Digital Imager) 1System, Imaging, Pulsed Echo, Ultrasonic 1Transducer, Ultrasonic, Diagnostic 1System, X-Ray, Mobile 1Table, Radiographic, Non-Tilting, Powered 1System, Nuclear Magnetic Resonance Imaging 1System, Imaging, Pulsed Doppler, Ultrasonic 1

Registration details (sample)

MarketIdentifierNameClass / date
USK240933CarbonCool® System2025-03-18
USK230241Jumong General2023-02-23
USK222080Garion Image-Intensified Fluoroscopic X-Ray System, Mobile2022-10-06

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