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INSIGHTRA MEDICAL, INC.

USA · Clarksville

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Canada, Hong Kong, Israel, Russia — 6 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

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

1valid listings

Class IV 1

ILIsraelAMAR

2registrations

RURussiaRoszdravnadzor

1active registrations

Class 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.

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

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)

Market	Identifier	Name	Class / date
US	K142192	Insightra Freedom Ventral Hernia Repair System	2015-05-07
US	K140967	FREEDOM INGUINAL HERNIA REPAIR IMPLANT-25MM/40MM/40MM WITH EXTENDED DISK	2014-06-10
US	K113552	FREEDOM INGUINAL HERNIA IMPLANT	2012-08-23
BR	80446140017	Modulare Fixador de Cateter	Class I
BR	80065320170	ReeTrakt Retrator	Class II
BR	80065320171	Reetrakt Retrator - Com Gancho de Aço Inoxidável	Class II

INSIGHTRA MEDICAL, INC.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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