HomeMalaysiaCareplus (M) Sdn Bhd

Careplus (M) Sdn Bhd

Malaysia · Negeri Sembilan Darul Khusus
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Taiwan — 3 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
10510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 10 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
1registered devices
Class I 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
0active device licences
TWTaiwanTFDA
1valid device licences
Class I 1
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 States0 registration records, 10 510(k), 0 PMA, 2 excluded
Brazil1 confirmed, 0 excluded
Saudi Arabia0 confirmed, 1 excluded
Manufacturer names merged into this page: Careplus (m) Sdn Bhd

Company information

Country
Malaysia
City
Negeri Sembilan Darul Khusus

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

22015
12016 · K152593
12017 · K162858
62021 · K211621

Registration details (sample)

MarketIdentifierNameClass / date
USK211621Latex Surgical Gloves, Powder Free with Protein claim (50 micrograms or less)2021-10-06
USK201857Powder Free Nitrile Examination Glove Black and Dual Color White-Blue2021-08-20
USK203705Latex Examination Glove, Powder free with Protein Content Labeling Claim (50 ug/g or less of total extractable Protein)2021-08-20
BR10330660117LUVA NITRÍLICA COM PÓ PARA PROCEDIMENTOS NÃO ESTÉREIS DESCARPACK IIIClass I

Similar companies

AAMEDIX GLOVE SDN BHD
Malaysia · markets 3
Advanced Safety Lifecare Sdn. Bhd.
Malaysia · markets 0
Angel sports sdn.bhd
Malaysia · markets 1
ATL Products Tech Sdn Bhd
Malaysia · markets 0
CCB Medical Devices Sdn Bhd
Malaysia · markets 2
CONCH HYGIENE PRODUCTS SDN BHD
Malaysia · markets 0
Is this your company? Claim the page, add information or report a data error.Claim / report an error →