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TZ MEDICAL, INC.

USA · Tualatin

✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Saudi Arabia, Canada, Taiwan, Australia, Hong Kong, Israel — 7 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

28listed device types

Class I 14Class II 11Class III 1unclassified 2

plus 34 registration records and 15 510(k), 1 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

2registered imported devices

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

CACanadaMDALL

3active device licences

Class II 3

12 including historic records

TWTaiwanTFDA

1valid device licences

Class II 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

8active ARTG entries

Class I 7IIa 1

HKHong KongMDACS

1valid listings

Class III 1

ILIsraelAMAR

4registrations

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 States34 registration records, 15 510(k), 1 PMA, 1 excluded

Saudi Arabia2 confirmed, 0 excluded

Canada3 confirmed, 0 excluded

Manufacturer names merged into this page: TZ MEDICAL, INC. · TZ Medical inc. · TZ Medical, Inc.

FDA 510(k) clearances by year

11992

11997

11998

31999

22000

12003

12004

12006

12011

12017

12018

12026

FDA listed device types

showing 8 of 28

Detector And Alarm, Arrhythmia 1Cable, Transducer And Electrode, Patient, (Including Connector) 1Transmitters And Receivers, Electrocardiograph, Telephone 1Electrode, Pacemaker, Temporary 1Syringe, Balloon Inflation 1Introducer, Catheter 1Trocar 1Holder, Head, Neurosurgical (Skull Clamp) 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K252772	Arc Adjustable Radial Cuff Compression Device	2026-05-22
US	K173563	ARC ADJUSTABLE RADIAL CUFF COMPRESSION DEVICE	2018-01-10
US	K163322	TZ SKULL PIN Adult	2017-02-23
SA	ME0000002026SFDAA00013	Wavelinq	—
SA	ME0000006593SFDAA00002	WRIST STRAPS KIT	—
CA	65447	TZ MEDICAL HEART AIDE	Class II
CA	65449	TZ MEDICAL PACE AIDE	Class II
CA	65451	TZ MEDICAL MONITORING ELECTRODES	Class II

TZ 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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