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Reichert, Inc.

USA · Depew

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 10 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

20listed device types

Class I 14Class II 6Class III 0

plus 31 registration records and 9 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class II 1

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 3Class III 1

13 including historic records

TWTaiwanTFDA

6valid device licences

Class I 1Class II 5

SGSingaporeHSA SMDR

6device registrations

CLASS B 6

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

10active ARTG entries

Class I 2IIa 7Class Im (measuring) 1

HKHong KongMDACS

1valid listings

Class II 1

ILIsraelAMAR

7registrations

RURussiaRoszdravnadzor

4active registrations

Class 2a 4

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 States31 registration records, 9 510(k), 0 PMA, 3 excluded

Brazil1 confirmed, 0 excluded

Canada4 confirmed, 0 excluded

Manufacturer names merged into this page: REICHERT INC. · REICHERT, INC.

FDA 510(k) clearances by year

22004 · K042831

22006 · K063750

12007 · K070534

22008 · K081756

12014 · K141954

12024 · K233516

FDA listed device types

showing 8 of 20

Tonometer, Ac-Powered 1Pad, Heating, Powered 1Camera, Ophthalmic, Ac-Powered 1System, Imaging, Pulsed Echo, Ultrasonic 1Biomicroscope, Slit-Lamp, Ac-Powered 1Tonometer, Manual 1Set, Lens, Trial, Ophthalmic 1Automated Colony Counter 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K233516	Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes (16305, 16306, 16318)	2024-05-01
US	K141954	XCEL 455 SLIT LAMP	2014-10-15
US	K081756	OCULAR RESPONSE ANALYZER	2008-08-07
BR	80117580299	Tonômetro de Aplanação	Class II
CA	68662	NON-CONTACT TONOMETER	Class II
CA	74047	SOCT COPERNICUS	Class II
CA	83202	FORESEE PHP SYSTEM (PREFERENTIAL HYPERACUITY PERIMETER)	Class II