Home›Taiwan›INNOCARE OPTOELECTRONICS CORP.

INNOCARE OPTOELECTRONICS CORP.

Taiwan · Tainan

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Brazil — 2 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

pendingnot queried

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

1listed device types

Class I 0Class II 1Class III 0

plus 12 registration records and 6 510(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

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

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.

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 States12 registration records, 6 510(k), 0 PMA, 2 excluded

Brazil3 confirmed, 0 excluded

Manufacturer names merged into this page: INNOCARE OPTOELECTRONICS CORP.

Registration details (sample)

Market	Identifier	Name	Class / date
US	K250211	Yushan X-Ray Flat Panel Detector	2025-07-22
US	K243171	Yushan X-Ray Flat Panel Detector	2024-12-19
US	K220510	Yushan X-Ray Flat Panel Detector with DROC	2022-04-14
BR	80867150122	SOFTWARE DO CONSOLE OPERACIONAL DO DETECTOR DE X- RAY FLAT PANEL RADIO	Class II
BR	80867150179	SOFTWARE DE DIGITALIZADOR DE IMAGENS RADIOGRAFICAS VOYANCE	Class II
BR	80867159006	FAMÍLIA DE DIGITALIZADOR DE IMAGENS RADIOGRÁFICAS YUSHAN	Class II

INNOCARE OPTOELECTRONICS CORP.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

Similar companies