HomeUnited Kingdom of Great Britain and Northern IrelandOptos Inc.

Optos Inc.

United Kingdom of Great Britain and Northern Ireland · Southborough
✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong — 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
5listed device types
Class I 1Class II 4Class III 0
plus 19 registration records and 15 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
3registered devices
Class II 3
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
0active device licences
12 including historic records
TWTaiwanTFDA
5valid device licences
Class II 5
SGSingaporeHSA SMDR
8device registrations
CLASS B 8
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
7active ARTG entries
Class I 1IIa 6
HKHong KongMDACS
4valid listings
Class II 4
ILIsraelAMAR
pendingnot queried
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 States19 registration records, 15 510(k), 0 PMA
Brazil3 confirmed, 0 excluded
Manufacturer names merged into this page: OPTOS PLC · Optos Inc. · OPTOS INC.

Company information

Country
United Kingdom of Great Britain and Northern Ireland
City
Southborough

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA 510(k) clearances by year

11999
12004
12006
22010
12011
12012
12013
12014
12015
12017
12018
12019
12023
12024

FDA listed device types

Ophthalmoscope, Laser, Scanning 1Tomography, Optical Coherence 1System, Image Management, Ophthalmic 1Ophthalmoscope, Ac-Powered 1Armrest, Wheelchair 1

Registration details (sample)

MarketIdentifierNameClass / date
USK233602P200TE (A10700)2024-05-09
USK231673P200TE (A10700)2023-08-18
USK190732P200TxE2019-07-31
BR80117580492CaliforniaClass II
BR80117580162OFTALMOSCÓPIO PANORÂMICO OPTOSClass II
BR80117580901SilverstoneClass II

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