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Optim, Inc.

USA · Sturbridge

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Canada, Israel — 3 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

3listed device types

Class I 1Class II 2Class III 0

plus 4 registration records and 6 510(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

3active device licences

Class II 3

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

4registrations

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 States4 registration records, 6 510(k), 0 PMA

Canada3 confirmed, 0 excluded

Manufacturer names merged into this page: OPTIM LLC

FDA 510(k) clearances by year

12008 · K080622

12009 · K091829

12012 · K122593

12013 · K130489

12021 · K200609

12026 · K254133

FDA listed device types

Nasopharyngoscope (Flexible Or Rigid) 1Led Light Source 1Camera, Television, Endoscopic, Without Audio 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K254133	ENTity USB Videoscope System	2026-05-14
US	K200609	ENTity WiFi Video Nasopharyngoscope System	2021-01-13
US	K130489	ELECTRODE, FLEXIBLE SUCTION COAGULATOR	2013-04-19
CA	65921	FIBER OPTIC NASOPHARYNGOSCOPE	Class II
CA	77262	ENTITY FIBER OPTIC NASOPHARYNGOSCOPE	Class II
CA	94438	RIGID ENDOSCOPE	Class II

Optim, 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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