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Katecho, Inc.

USA · Des Moines

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Australia — 2 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

34listed device types

Class I 3Class II 27Class III 3unclassified 1

plus 46 registration records and 26 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

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

1active ARTG entries

Class I 1

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 States46 registration records, 26 510(k), 0 PMA

Manufacturer names merged into this page: KATECHO LLC

FDA 510(k) clearances by year

11984

11985

11986

21990

11991

51992

21993

31994

21995

11998

11999

42000

22001

FDA listed device types

showing 8 of 34

Detector And Alarm, Arrhythmia 1Uterine Electromyographic Monitor 1Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) 1Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) 1Electromyograph, Diagnostic 1Transmitters And Receivers, Physiological Signal, Radiofrequency 1Device, Sleep Assessment 1Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K012404	K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-85	2001-10-12
US	K010543	KM-30 TENS ELECTRODE	2001-05-23
US	K003228	K-DEFIB/PACE MULTIFUCTION PEDIATRIC ELECTRODE, MODEL KDP-70A	2000-12-14

Katecho, 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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