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Home›China›Seplou (Zhuhai) Co., Ltd.

Seplou (Zhuhai) Co., Ltd.

China · Zhuhai Guangdong
✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Hong Kong — 2 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
7listed device types
Class I 1Class II 6Class III 0
plus 7 registration records and 2 510(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
1valid listings
Class II 1
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 States7 registration records, 2 510(k), 0 PMA
Brazil0 confirmed, 3 excluded
Manufacturer names merged into this page: SEPLOU (ZHUHAI) CO.,LTD.

Company information

Country
China
City
Zhuhai Guangdong

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

22025 · K250049

FDA listed device types

Dislodger, Stone, Basket, Ureteral, Metal 1Endoscopic Access Overtube, Gastroenterology-Urology 1Bottle, Collection, Vacuum 1Dilator, Urethral 1Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt 1Ureteroscope And Accessories, Flexible/Rigid 1Toothbrush, Manual 1

Registration details (sample)

MarketIdentifierNameClass / date
USK250049Medical Video Endoscope [Standard Deflection] (URS3005); Medical Video Endoscope [Reverse Deflection] (URS3005E); Medical Video Endoscope [Standard Deflection] (URS3006); Medical Video Endoscope [Reverse Deflection] (URS3006E); Medical Video Endoscope [Standard Deflection] (URS3016); Medical Video Endoscope [Reverse Deflection] (URS3016E); Image processor (DIS8000)2025-08-26
USK243025Ureteral Access Sheath2025-01-30

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