HomeChinaShenzhen Osto Technology Company Limited

Shenzhen Osto Technology Company Limited

China · Shenzhen
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Canada, Australia — 3 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
11listed device types
Class I 3Class II 8Class III 0
plus 15 registration records and 12 510(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
1active device licences
Class II 1
2 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
4active ARTG entries
Class I 3IIa 1
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 States15 registration records, 12 510(k), 0 PMA
Canada1 confirmed, 0 excluded
Manufacturer names merged into this page: Shenzhen OSTO Medical Technology Company Limited · SHENZHEN OSTO TECHNOLOGY COMPANY LIMITED
Same-named companies — This database also contains companies with near-identical names: Shenzhen OSTO Medical Technology Company Limited. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
China
City
Shenzhen

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

12014
32018
22019 · K190673
12020 · K190783
42021 · K211942
12022 · K213056

FDA listed device types

showing 8 of 11
Stimulator, Nerve, Transcutaneous, Over-The-Counter 1Pad, Heating, Powered 1Stimulator, Muscle, Powered 1Light Based Over The Counter Wrinkle Reduction 1Stimulator, Muscle, Powered, For Muscle Conditioning 1Stimulator, Nerve, Transcutaneous, For Pain Relief 1Over-The-Counter Powered Light Based Laser For Acne 1Stimulator, Electrical, Transcutaneous, For Arthritis 1

Registration details (sample)

MarketIdentifierNameClass / date
USK213056LED Facial Mask2022-07-07
USK211942Heating Lumbar Therapy Cushion (Model: AST-622, AST-622B, AST-623, AST-623B)2021-12-13
USK212989Low-frequency Stimulator (Model: AST-645, AST-646)2021-11-22
CA97336ELECTRONIC MUSCLE STIMULATORClass II

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