Home›USA›Martech Medical Products Inc.

Martech Medical Products Inc.

USA · Harleysville PA · www.martechmedical.com

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, South Korea — 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

0UDI-DI device records

USUnited StatesFDA openFDA

55listed device types

Class I 17Class II 36Class III 1unclassified 1

plus 169 registration records and 10 510(k)

UKUnited KingdomMHRA PARD

0registered device records

BRBrazilANVISA

3registered devices

Class I 2Class II 1

4 including historic records

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

Import 2

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 States169 registration records, 10 510(k), 0 PMA

Brazil3 confirmed, 0 excluded

Manufacturer names merged into this page: MARTECH MEDICAL PRODUCTS S. DE RL. DE CV. · MARTECH MEDICAL PRODUCTS · Martech Medical Product · Martech Medical Products

FDA 510(k) clearances by year

11989

11991

11992

31993

11996

12010

12012

12013

FDA listed device types

showing 8 of 55

Fluorometer, Lead (Dedicated Instruments) 1Cystoscope And Accessories, Flexible/Rigid 1Catheter, Hemodialysis, Non-Implanted 1Accessories, A-V Shunt 1Kit, Repair, Catheter, Hemodialysis 1Port & Catheter, Implanted, Subcutaneous, Intravascular 1Injector And Syringe, Angiographic 1Needle, Hypodermic, Single Lumen 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K130855	PTFE SUPER SHEATH INTRODUCER	2013-07-29
US	K120617	PTFE SUPER SHEATH INTRODUCER	2012-11-19
US	K101399	COAXIAL INTRODUCER SET	2010-06-17
BR	10312210045	KIT REPARADOR PARA CATETER DE HEMODIÁLISE E AFÉRESE	Class I
BR	10312210027	AGULHA DE PUNÇÃO	Class I
BR	10312210029	DISPOSITIVO INTRODUTOR MICRO-STICK NITINOL	Class II

Martech Medical Products Inc.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

Similar companies