HomeChinaSandstone Medical (Suzhou), Inc.

Sandstone Medical (Suzhou), Inc.

China · Suzhou
✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Canada, Singapore, Australia, Hong Kong — 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
pendingnot queried
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
1listed device types
Class I 0Class II 1Class III 0
plus 3 registration records and 3 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
11registered devices
Class I 1Class II 10
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
pendingnot queried
SGSingaporeHSA SMDR
2device registrations
CLASS B 2
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
3active ARTG entries
IIa 3
HKHong KongMDACS
4valid listings
Class II 4
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 States3 registration records, 3 510(k), 0 PMA, 2 excluded
Brazil11 confirmed, 0 excluded
Manufacturer names merged into this page: SANDSTONE MEDICAL (SUZHOU) INC.

Company information

Country
China
City
Suzhou

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

12021 · K193422
12022 · K210864
12026 · K252908

FDA listed device types

Needle, Hypodermic, Single Lumen 1

Registration details (sample)

MarketIdentifierNameClass / date
USK252908Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen Needle; Easydrip Plus Pro Pen Needle2026-03-25
USK210864Safety Pen Needle2022-02-17
USK193422Easydrip Pen Needle, Easydrip Plus Pen Needle2021-02-02
BR82316959002Agulha para Caneta de InsulinaClass II
BR10098719017Agulhas para Caneta de Insulina UNIQMED com Dispositivo de SegurançaClass II
BR81840549039CÂNULA PARA CANETA DOSADORA DE INSULINAClass II

Similar companies

Acoresmed Co., Ltd.
China · markets 1
Aimagine Care Technology Co., Ltd.
China · markets 2
Allmed Medical Products Co. Ltd.
China · markets 12
ALTON(shanghai)medical Instruments Co.,Ltd
China · markets 12
Ambulanc (Shenzhen) Tech. Co. Ltd.
China · markets 10
Andon Health Co., Ltd.
China · markets 10
Is this your company? Claim the page, add information or report a data error.Claim / report an error →