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Home›Malaysia›CHEEN HOUNG ENTERPRISE CO. LTD. / PLAXTRON INDUSTRIAL

CHEEN HOUNG ENTERPRISE CO. LTD. / PLAXTRON INDUSTRIAL

Malaysia
✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Brazil — 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
23listed device types
Class I 11Class II 12Class III 0
plus 31 registration records and 1 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
4registered devices
Class I 1Class II 3
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
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
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 States31 registration records, 1 510(k), 0 PMA
Brazil4 confirmed, 0 excluded
Manufacturer names merged into this page: PLAXTRON INDUSTRIAL (M) SDN. BHD. · PLAXTRON INDUSTRIAL (M)SDN BHD · CHEEN HOUNG ENTERPRISE CO. LTD. / PLAXTRON INDUSTRIAL
Same-named companies — This database also contains companies with near-identical names: PLAXTRON INDUSTRIAL (M) SDN. BHD.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
Malaysia

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

12012 · K120065

FDA listed device types

showing 8 of 23
Spirometer, Therapeutic (Incentive) 1Filter, Bacterial, Breathing-Circuit 1Monitor, Airway Pressure (Includes Gauge And/Or Alarm) 1Attachment, Breathing, Positive End Expiratory Pressure 1Nebulizer (Direct Patient Interface) 1Tubes, Gastrointestinal (And Accessories) 1Resuscitator, Manual, Non Self-Inflating 1Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase 1

Registration details (sample)

MarketIdentifierNameClass / date
USK120065PLAXTRON SUCTION UNIT, MODEL 88AA51/88AA61 SERIES2012-04-03
BR10299940009SONDA LARINGEA TIPO MASCARA MEDTECHClass II
BR10299949001SONDA LARÍNGEA TIPO MÁSCARA MEDTECHClass II
BR10299940012SONDA NASOFARÍNGEA MEDTECHClass II

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