HomeKorea, RepublicPOTEC CO., LTD.

POTEC CO., LTD.

Korea, Republic · Daejeon
✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Saudi Arabia, Taiwan, Israel, Russia — 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
4listed device types
Class I 4Class II 0Class III 0
plus 4 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
5registered devices
Class I 2Class II 3
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
7registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
1valid device licences
Class I 1
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
8registrations
RURussiaRoszdravnadzor
6active registrations
Class 2a 6
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, 0 510(k), 0 PMA
Brazil5 confirmed, 0 excluded
Saudi Arabia7 confirmed, 0 excluded
Manufacturer names merged into this page: POTEC CO., LTD. · POTEC CO., LTD · POTEC CO. LTDA

Company information

Country
Korea, Republic
City
Daejeon

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 listed device types

Projector, Ophthalmic 1Refractor, Manual, Non-Powered, Including Phoropter 1Refractometer, Ophthalmic 1Instrument, Measuring, Lens, Ac-Powered 1

Registration details (sample)

MarketIdentifierNameClass / date
BR80497819021AUTO REFRATOR COM CERATÔMETRO POTECClass II
BR80497819018REFRATOR DIGITAL POTECClass II
BR80497819026AUTO REFRATOR POTECClass II
SAME0000001524SFDAA00024LCD Chart
SAME0000001524SFDAA00025Digital Refractor

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