HomeMalaysiaBACTIGUARD (South East Asia) Sdn. Bhd.

BACTIGUARD (South East Asia) Sdn. Bhd.

Malaysia · Penang Science Park Pulau Pinang
✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Taiwan, Australia, Hong Kong, Israel — 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
1listed device types
Class I 0Class II 0Class III 0unclassified 1
plus 1 registration records and 0 510(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
1valid device licences
Class II 1
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
5active ARTG entries
Class III 2IIb 3
HKHong KongMDACS
2valid listings
Class III 2
ILIsraelAMAR
1registrations
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 States1 registration records, 0 510(k), 0 PMA
Canada0 confirmed, 1 excluded
Manufacturer names merged into this page: BACTIGUARD (South East Asia) Sdn. Bhd.

Company information

Country
Malaysia
City
Penang Science Park Pulau Pinang

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 listed device types

Dressing, Wound, Drug 1

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 →