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Home›USA›OPHTHALMIC INTERNATIONAL, INC.

OPHTHALMIC INTERNATIONAL, INC.

USA · Fountain Hills
✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, South Korea — 6 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
24listed device types
Class I 13Class II 11Class III 0
plus 26 registration records and 6 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
35registered devices
Class I 1Class II 34
38 including historic records
SASaudi ArabiaSFDA
5registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
18active device licences
Class II 18
39 including historic records
TWTaiwanTFDA
1valid device licences
Class I 1
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
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.

Saudi Arabia: under each source's terms, this site shows record counts and official links only — no record details on pages, in search, in the member area or in exports.

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 States26 registration records, 6 510(k), 0 PMA, 40 excluded
Brazil35 confirmed, 5 excluded
Saudi Arabia5 confirmed, 0 excluded
Canada18 confirmed, 2 excluded
Manufacturer names merged into this page: D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. · D.O.R.C DUTCH OPHTHALMIC RESEARCH CENTER (INTERNATIONAL) B.V. · OPHTHALMIC INTERNATIONAL, INC. · D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER (INTERNATIONAL) B.V. · D.O.R.C Dutch Ophthalmic Research Center (International) BV · DUCTH OPHTHALMIC RESEARCH CENTER INTERNATIONAL BV

Company information

Country
USA
City
Fountain Hills

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

12006 · K062895
12009 · K081877
12015 · K142877
12017 · K160591
12019 · K190875
12022 · K213467

FDA listed device types

showing 8 of 24
Electrosurgical, Cutting & Coagulation & Accessories 1Instrument, Vitreous Aspiration And Cutting, Ac-Powered 1Laser, Ophthalmic 1Syringe, Piston 1Photocoagulator And Accessories 1Endoilluminator 1Lens, Contact, Polymethylmethacrylate, Diagnostic 1Unit, Cryophthalmic, Ac-Powered 1

Registration details (sample)

MarketIdentifierNameClass / date
USK213467EVA NEXUS Ophthalmic Surgical System2022-06-14
USK190875EVA, anterior machine, EVA, combined machine, EVA combined machine with laser (DORC connector), EVA combined machine with laser (SMA connector)2019-09-25
USK160591D.O.R.C. Disposable Cryo Probe2017-01-23
BR80047309230Pack EVA NEXUS, TDC combinado (23 gauge, 25 gauge e 27 gauge)Class II
BR80047309231Pack EVA NEXUS, TDC combinado (23 gauge, 25 gauge e 27 gauge)Class II
BR80047309174Tubos descartáveis completos com filtro para troca de fluido de arClass II
CA8279VITREOUS SHAVERClass II
CA9895CRYOPROBEClass II
CA64501DISPOSABLE ECKARDT MEMBRANE PICClass II

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