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Optomed Corp.

Finland · Oulu Pohjois-Pohjanmaa

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Saudi Arabia, Singapore, Israel, Russia — 5 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

2listed device types

Class I 0Class II 2Class III 0

plus 6 registration records and 7 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

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

SASaudi ArabiaSFDA

1registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

2device registrations

CLASS B 2

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

RURussiaRoszdravnadzor

2active registrations

Class 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 States6 registration records, 7 510(k), 0 PMA, 1 excluded

Saudi Arabia1 confirmed, 1 excluded

Canada0 confirmed, 1 excluded

Manufacturer names merged into this page: Optomed · Optomed Oy

Registration details (sample)

Market	Identifier	Name	Class / date
US	K180378	Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior Module	2018-04-05
US	K163021	HAAG-STREIT FUNDUS MODULE 300	2017-04-11
US	K132186	OPTOMED SMARTSCOPE M5 / OPTOMED SMARTSCOPE EY4 / OPTOMED SMARTSCOPE ES2	2013-12-18
SA	ME0000003561SFDAA00002	Optomed Aurora Camera	—

Optomed Corp.

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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