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NEITZ INSTRUMENTS COMPANY, LTD.

Japan · Chiyoda-Ku T?Ky?

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Saudi Arabia, 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

12listed device types

Class I 10Class II 2Class III 0

plus 17 registration records and 24 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

3registered devices

Class I 3

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

SASaudi ArabiaSFDA

10registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

16valid device licences

Class I 8Class II 8

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

4active ARTG entries

Class I 4

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

3registrations

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 States17 registration records, 24 510(k), 0 PMA

Brazil3 confirmed, 0 excluded

Saudi Arabia10 confirmed, 0 excluded

Manufacturer names merged into this page: NEITZ INSTRUMENTS COMPANY, LTD. · NEITZ INSTRUMENTS CO. LTD. · NEITZ INSTRUMENTS Co.,Ltd. · Neitz Instruments Co. Ltd

FDA 510(k) clearances by year

91994

141995 · K951341

11997 · K972440

FDA listed device types

showing 8 of 12

Device, Measuring, Lens Radius, Ophthalmic 1Light, Examination, Medical, Battery Powered 1Lens, Condensing, Diagnostic 1Loupe, Binocular, Low Power 1Anomaloscope 1Retinoscope, Battery-Powered 1Transilluminator, Battery-Powered 1Headlamp, Operating, Battery-Operated 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K972440	CATARACTSCREENER CT - S	1997-09-30
US	K951341	NEITZ SLIT LAMP SL-H2	1995-06-15
US	K951337	FIBER HEAD LIGHT FH-300	1995-06-08
BR	10364090008	Lupa Binocular Neitz	Class I
BR	80519700005	OTOSCÓPIO NEITZ FO	Class I
BR	80519709001	LUPA BINOCULAR	Class I
SA	ME0000010510SFDAA00002	Streak Retinoscope	—
SA	ME0000010510SFDAA00002	Streak Retinoscope	—

NEITZ INSTRUMENTS COMPANY, LTD.

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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