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Home›USA›INSIGHTRA MEDICAL INC. – EUA

INSIGHTRA MEDICAL INC. – EUA

USA
✓ 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
11listed device types
Class I 5Class II 6Class III 0
plus 11 registration records and 4 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
4registered devices
Class I 1Class II 3
5 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
2 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 States11 registration records, 4 510(k), 0 PMA
Brazil4 confirmed, 0 excluded
Manufacturer names merged into this page: INSIGHTRA MEDICAL, INC. · INSIGHTRA MEDICAL · INSIGHTRA MEDICAL INC. – EUA
Same-named companies — This database also contains companies with near-identical names: INSIGHTRA MEDICAL, INC.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA

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

12009 · K082746
12012 · K113552
12014 · K140967
12015 · K142192

FDA listed device types

showing 8 of 11
System, Balloon, Intra-Aortic And Control 1Arthroscope 1Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass 1Endoscopic Contamination Prevention Sheath 1Syringe, Balloon Inflation, Exempt 1Ligator, Hemorrhoidal 1Accessories, Arthroscopic 1Retractor 1

Registration details (sample)

MarketIdentifierNameClass / date
USK142192Insightra Freedom Ventral Hernia Repair System2015-05-07
USK140967FREEDOM INGUINAL HERNIA REPAIR IMPLANT-25MM/40MM/40MM WITH EXTENDED DISK2014-06-10
USK113552FREEDOM INGUINAL HERNIA IMPLANT2012-08-23
BR80446140017Modulare Fixador de CateterClass I
BR80065320170ReeTrakt RetratorClass II
BR80065320171Reetrakt Retrator - Com Gancho de Aço InoxidávelClass II

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