HomeMalaysiaMultisafe Sdn. Bhd.

Multisafe Sdn. Bhd.

Malaysia · Bidor
✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Saudi Arabia, Canada, Taiwan, Australia — 5 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
2listed device types
Class I 2Class II 0Class III 0
plus 8 registration records and 8 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
8registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
3 including historic records
TWTaiwanTFDA
1valid device licences
Class I 1
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
1active ARTG entries
Class I 1
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 States8 registration records, 8 510(k), 0 PMA
Saudi Arabia8 confirmed, 0 excluded
Manufacturer names merged into this page: MULTISAFE SDN BHD · MULTISAFE SDN. BHD. · Multisafe Sdn. Bhd. · Multisafe Sdn.Bhd

Company information

Country
Malaysia
City
Bidor

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

42000 · K001497
12001 · K011293
22007 · K062526
12018 · K161085

FDA listed device types

Polymer Patient Examination Glove 1Latex Patient Examination Glove 1

Registration details (sample)

MarketIdentifierNameClass / date
USK161085Nitrile Patient Examination Powder Free Glove, Textured, Black2018-07-05
USK062526BLUE POWDERED LATEX EXAMINATION GLOVES, NON-STERILE2007-04-13
USK062527BLUE POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE2007-02-20
SAME0000009206SFDAA00001PHMCO LATEX POWDER FREE EXAMINATION GLOVES
SAME0000009206SFDAA00002PHMCO LATEX POWDER FREE EXAMINATION GLOVES

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