Contact:haixiao@sungolytest.com+86 158 2169 5110 (WeChat)+86 132 4819 8029 Members 中文
Home›Taiwan›Smedtrum Medical Technology Co., Ltd.

Smedtrum Medical Technology Co., Ltd.

Taiwan · New Taipei City
✓ Record-verifiedregistrations found in 1 markets

This company has registrations in United States — 1 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
2listed device types
Class I 0Class II 2Class III 0
plus 5 registration records and 5 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
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 States5 registration records, 5 510(k), 0 PMA
Manufacturer names merged into this page: SMEDTRUM MEDICAL TECHNOLOGY CO. LTD.

Company information

Country
Taiwan
City
New Taipei City

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

12022 · K221597
22023 · K231394
22024 · K240482

FDA listed device types

Powered Light Based Non-Laser Surgical Instrument With Thermal Effect 1Powered Laser Surgical Instrument 1

Registration details (sample)

MarketIdentifierNameClass / date
USK240482Intense Pulsed Light System (ST-690)2024-05-17
USK240118Picosecond Nd:YAG Laser System2024-04-30
USK231394Intense Pulsed Light System2023-08-09

Similar companies

Abletech Orthopedics Corporation
Taiwan · markets 3
Aero Pro Co., Ltd.
Taiwan · markets 2
AiQ Smart Clothing Inc.
Taiwan · markets 0
Anest Iwata Sparmax Co., Ltd.
Taiwan · markets 3
ANGELINE GROUP LTD
Taiwan · markets 1
Apex Biotechnology Corporation
Taiwan · markets 6
Is this your company? Claim the page, add information or report a data error.Claim / report an error →