HomeKorea, RepublicShina Corporation

Shina Corporation

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

This company has registrations in United States, Brazil, Canada, Taiwan, Australia, 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
5listed device types
Class I 0Class II 5Class III 0
plus 16 registration records and 4 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
1registered devices
Class II 1
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
2 including historic records
TWTaiwanTFDA
1valid device licences
Class II 1
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
2active ARTG entries
IIa 2
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
1active registrations
Class 2a 1
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 States16 registration records, 4 510(k), 0 PMA, 4 excluded
Brazil1 confirmed, 0 excluded
Canada0 confirmed, 1 excluded
Manufacturer names merged into this page: SHINA CORP. · SHINA CORPORATION

Company information

Country
Korea, Republic
City
Chungcheongnam-Do

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

12007 · K071947
12009 · K091167
12012 · K113186
12023 · K222417

FDA listed device types

Container, Sharps 1Syringe, Piston 1Syringe, Antistick 1Endoilluminator 1Needle, Hypodermic, Single Lumen 1

Registration details (sample)

MarketIdentifierNameClass / date
USK222417Shina Safety Needle2023-03-20
USK113186STERILE INSULIN PEN NEEDLE2012-04-12
USK091167SHINA INSULIN SYRINGE-INCLUDING ACCU-SURE INSULIN SYRINGES2009-08-06
BR10098719037SERINGAS PARA INSULINA COM AGULHA - UNIQMEDClass II

Similar companies

A-ZoneTech Co., LTD
Korea, Republic · markets 0
AB Medical, Inc.
Korea, Republic · markets 8
Ace Medical Co., Ltd
Korea, Republic · markets 9
AIT Studio Co., Ltd.
Korea, Republic · markets 1
AITRICS CO.,LTD
Korea, Republic · markets 2
Allmedicus Co., Ltd.
Korea, Republic · markets 4
Is this your company? Claim the page, add information or report a data error.Claim / report an error →