Home›USA›INSITU TECHNOLOGIES, INC.

INSITU TECHNOLOGIES, INC.

USA · Saint Paul

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Israel — 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

7listed device types

Class I 0Class II 3Class III 3unclassified 1

plus 9 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

9registered devices

Class I 3Class II 6

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

0active device licences

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

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 States9 registration records, 0 510(k), 0 PMA, 1 excluded

Brazil9 confirmed, 0 excluded

Manufacturer names merged into this page: INSITU TECHNOLOGIES, INC. · INSITU TECHNOLOGIES INC · INSITU TECHNOLOGIES, INC

FDA listed device types

Coronary Drug-Eluting Stent 1Iliac Covered Stent, Arterial 1Drug-Coated Peripheral Transluminal Angioplasty Catheter 1Coronary Covered Stent 1Catheter, Intravascular, Diagnostic 1Wire, Guide, Catheter 1Introducer, Catheter 1

Registration details (sample)

Market	Identifier	Name	Class / date
BR	10309090015	LINHA DE INJEÇÃO ALTA PRESSÃO PVC INSITU	Class II
BR	10309090010	DISPOSITIVO PLASTICO MANIPULADOR DE TORCAO	Class I
BR	10309090031	Kit Introdutor Insitu	Class II

INSITU TECHNOLOGIES, INC.

Registrations by market

How these numbers were verified

Company information

FDA listed device types

Registration details (sample)

Similar companies