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Opti Medical Systems, Inc.

USA · Roswell

✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, Australia, Israel, Russia — 8 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

16listed device types

Class I 6Class II 10Class III 0

plus 13 registration records and 3 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

13registered devices

Class II 13

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

1active device licences

Class III 1

3 including historic records

TWTaiwanTFDA

1valid device licences

Class II 1

SGSingaporeHSA SMDR

1device registrations

CLASS C 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

3active ARTG entries

IVD Class 1 2IVD Class 2 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

3registrations

RURussiaRoszdravnadzor

3active registrations

Class 1 1Class 2a 2

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 States13 registration records, 3 510(k), 0 PMA, 5 excluded

Brazil13 confirmed, 0 excluded

Canada1 confirmed, 1 excluded

Manufacturer names merged into this page: OPTI MEDICAL SYSTEMS INC. · OPTI MEDICAL SYSTEMS, INC.

FDA 510(k) clearances by year

12011 · K093280

12013 · K131126

12021 · K200986

FDA listed device types

showing 8 of 16

Oximeter To Measure Hemoglobin 1System, Hemoglobin, Automated 1Glucose Oxidase, Glucose 1Oximeter 1Electrode, Ion-Specific, Chloride 1Electrode, Ion Specific, Urea Nitrogen 1Electrode, Ion Specific, Sodium 1Electrode, Ion Specific, Calcium 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K200986	OPTI® B-Lac Cassette	2021-08-02
US	K131126	OPTI CCA-TS2	2013-08-22
US	K093280	OPTI CCA-TS, B-LAC CASSETTE MODEL BP7561	2011-01-07
BR	80102512276	CASSETE E-Lyte CCA	Class II
BR	80102511460	ANALISADOR DE PH, GASES E ELETRÓLITOS OPTI	Class II
BR	80102511521	CASSETE OPTI CCA TIPO B	Class II
CA	74185	OPTI R BLOOD GAS ANALYZER	Class III

Opti Medical Systems, 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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