✓ Record-verifiedregistrations found in 10 markets
This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 10 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
169listed device types
Class I 146Class II 23Class III 0
plus 598 registration records and 80 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
51registered devices
Class I 49Class II 2
91 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
20active device licences
Class II 16Class III 4
86 including historic records
TWTaiwanTFDA
5valid device licences
Class I 3Class II 2
SGSingaporeHSA SMDR
8device registrations
CLASS B 5CLASS C 2CLASS D 1
KRSouth KoreaMFDS GMP
4GMP quality-system certificates
Import 4
AUAustraliaTGA ARTG
273active ARTG entries
Class I 207Class III 5IIa 26IIb 33Class Im (measuring) 1Class Is (sterile) 1
HKHong KongMDACS
5valid listings
Class II 1Class III 4
ILIsraelAMAR
7registrations
RURussiaRoszdravnadzor
11active registrations
Class 1 1Class 2a 8Class 2b 1Class 3 1
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.
Australia, Hong Kong, Singapore, Israel: under each source's terms, this site shows record counts and official links only — no record details on pages, in search, in the member area or in exports.
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 States598 registration records, 80 510(k), 0 PMA
Brazil51 confirmed, 0 excluded
Canada20 confirmed, 0 excluded
Manufacturer names merged into this page: KLS Martin SE & Co. KG · KLS MARTIN SE & CO. KG · KLS-Martin L.P. · KLS Martin Malaysia Sdn. Bhd. · KLS MARTIN L.P. · GEBRUDER MARTIN GMBH & CO. KG A COMPANY OF THE KLS MARTIN GROUP
Same-named companies — This database also contains companies with near-identical names: Kls Martin GmbH + Co. KG, KLS MARTIN DO BRASIL EQUIPAMENTOS MEDICOS LTDA, KLS-Martin L.P., KLS Martin Malaysia Sdn. Bhd.. Company name alone cannot separate their registrations, so the figures below may include either.
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.