HomeMalaysiaDISPO-MED (MALAYSIA) SDN BHD

DISPO-MED (MALAYSIA) SDN BHD

Malaysia · Shah Alam Selangor
✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Taiwan, Singapore, Australia — 4 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
3listed device types
Class I 2Class II 1Class III 0
plus 3 registration records and 1 510(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
3valid device licences
Class I 3
SGSingaporeHSA SMDR
1device registrations
CLASS B 1
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
4active ARTG entries
Class I 1IIa 3
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 States3 registration records, 1 510(k), 0 PMA
Manufacturer names merged into this page: DISPO-MED (MALAYSIA) SDN BHD

Company information

Country
Malaysia
City
Shah Alam Selangor

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 · K143127

FDA listed device types

Accessory, Surgical Apparel 1Mask, Oxygen 1Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase 1

Registration details (sample)

MarketIdentifierNameClass / date
USK143127CO2-Mas, Oxygen Delivery/ CO2 sampling cannula style, CO2 sampling only style2015-02-13

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