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Home›Malaysia›MAERSK MEDICAL SDN.BHD

MAERSK MEDICAL SDN.BHD

Malaysia · Kulim
✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Canada — 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
13510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 13 510(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
1active device licences
Class II 1
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 States0 registration records, 13 510(k), 0 PMA
Canada1 confirmed, 0 excluded
Manufacturer names merged into this page: MAERSK MEDICAL SDN.BHD
Same-named companies — This database also contains companies with near-identical names: Maersk Medical A/S. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
Malaysia
City
Kulim

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

21997
11998
71999 · K990111
12000 · K002138
22001 · K011071

Registration details (sample)

MarketIdentifierNameClass / date
USK011071PARADIGM QUICK-SET INFUSION SET2001-06-07
USK004028ARGLAES-AB ANTIMICROBIAL BARRIER POWDER DRESSING2001-03-27
USK002138PARADIGM SILHOUETTE, MODELS MMT-377, 378, 379, 3802000-08-29
CA24828100% SILICONE FOLEY CATHETERClass II

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