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KONAN MEDICAL USA, INC.

USA · Irvine

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Australia, Israel — 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

8listed device types

Class I 4Class II 4Class III 0

plus 9 registration records and 7 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

3registered devices

Class I 1Class II 2

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

4active device licences

Class II 4

9 including historic records

TWTaiwanTFDA

1valid device licences

Class I 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

2active ARTG entries

Class I 2

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

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, 7 510(k), 0 PMA, 1 excluded

Brazil3 confirmed, 0 excluded

Canada4 confirmed, 0 excluded

Manufacturer names merged into this page: KONAN MEDICAL USA, INC. · KONAN MEDICAL, INC. · KONAN MEDICAL INC. · KONAN MEDICAL USA

FDA 510(k) clearances by year

11995

12004

12008

12009

12012

12020

12021

FDA listed device types

Perimeter, Automatic, Ac-Powered 1Stand, Instrument, Ophthalmic, Non-Powered 1Pupillograph 1Tester, Color Vision 1Electrode, Cutaneous 1Stimulator, Photic, Evoked Response 1System, Image Management, Ophthalmic 1Microscope, Specular 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K203244	CellChek 20 rc	2021-06-15
US	K191558	Konan Specular Microscope XVII	2020-03-26
US	K120264	KONAN SPECULAR MICROSCOPE XIV	2012-04-11
BR	82236550004	Família Konan CellChek D	Class II
BR	80470619002	Microscópio Especular Konan	Class I
BR	81346500070	Microscópio Especular	Class II
CA	35514	SP-9000 SPECULAR MICROSCOPE	Class II
CA	35515	SP-4000 SPECULAR MICROSCOPE	Class II
CA	88210	RAPDX PUPILLOGRAPH	Class II

KONAN MEDICAL USA, 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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