HomeJapanSUN MEDICAL CO., LTD.

SUN MEDICAL CO., LTD.

Japan · Arlington
✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Canada, Taiwan, South Korea, Australia, Russia — 7 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
1listed device types
Class I 0Class II 1Class III 0
plus 1 registration records and 6 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
2registered devices
Class II 2
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
1active device licences
Class II 1
TWTaiwanTFDA
7valid device licences
Class I 1Class II 6
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
1active ARTG entries
IIa 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
5active registrations
Class 2a 5
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 States1 registration records, 6 510(k), 0 PMA, 100 excluded
Brazil2 confirmed, 9 excluded
Saudi Arabia0 confirmed, 5 excluded
Canada1 confirmed, 3 excluded
Manufacturer names merged into this page: SUN MEDICAL CO., LTD. · SUN MEDICAL INC. · SUN MEDICAL CO. LTD

Company information

Country
Japan
City
Arlington

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

11985 · K845006
11988 · K874948
11991 · K911154
11992 · K921963
22015 · K150511

FDA listed device types

Cement, Dental 1

Registration details (sample)

MarketIdentifierNameClass / date
USK150511Coating Material2015-05-27
USK143265Acrylic Block2015-04-14
USK921963DISPOSABLE, FILTERED INSUFFLATION TUBING, 92-9001992-09-11
BR81593399016Super-Bond Universal Starter KitClass II
BR81593399017Super-Bond Universal KitClass II
CA28300SFE-200 SMOKE AND FLUID EVACUATION SYSTEMClass II

Similar companies

A2MediteX Corporation
Japan · markets 0
ACTIF CORPORATION CO., LTD
Japan · markets 0
Actment Co., Ltd
Japan · markets 0
Advanced Photonics, Inc.
Japan · markets 1
Advantec Toyo Kaisha, Ltd.
Japan · markets 0
ALCARE Co.,Ltd
Japan · markets 4
Is this your company? Claim the page, add information or report a data error.Claim / report an error →