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Home›USA›Surgical Instrument Systems (Sis), Ltd.

Surgical Instrument Systems (Sis), Ltd.

USA · Irvine
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Canada — 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
5510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 5 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
1registered devices
Class II 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
2active device licences
Class II 2
6 including historic records
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, 5 510(k), 0 PMA, 4 excluded
Brazil1 confirmed, 1 excluded
Canada2 confirmed, 1 excluded
Manufacturer names merged into this page: SIS LTD., SURGICAL INSTRUMENT SYSTEMS LTD. · SIS LTD., SURGICAL INSTRUMENT SYSTEMS
Same-named companies — This database also contains companies with near-identical names: SIS LTD., SURGICAL INSTRUMENT SYSTEMS LTD.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
Irvine

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

12000 · K993190
22005 · K051940
12009 · K082871
12019 · K182659

Registration details (sample)

MarketIdentifierNameClass / date
USK182659Galilei G6 Lens Professional2019-07-25
USK082871XACT LENS INSERTER SYSTEM, MODELS 6MM, 7MM2009-07-09
USK051940CM 3910 ROTATING DOUBLE SCHEIMPFLUG CAMERA2005-09-28
BR80102511145GALILEI ANALISADOR DE SCHEIMPFLUG DUPLOClass II
CA65252AMADEUS MICROKERATOME SYSTEMClass II
CA67298AMADEUS II MICROKERATOME SYSTEMClass II

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