SEPLOU (ZHUHAI) CO.,LTD.

FDA Device Registration & Listing · Zhuhai Guangdong, CN · Registration 3035480112

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3035480112
FEI Number
3035480112
Entity Name
SEPLOU (ZHUHAI) CO.,LTD.
City/State/Country
Zhuhai Guangdong, CN
Establishment Address
5th Floor, Building 1, No. 8, Keji 10th Road, Tangjiawan Town, High-tech Zone, Zhuhai Guangdong 519085, CN
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
SEPLOU (ZHUHAI) CO.,LTD. (Owner Number: 10092239)
Owner / Operator Contact Address
5th Floor, Building 1, No. 8, Keji 10th Road, Tangjiawan Town, High-tech Zone, Zhuhai, CN-GD 519085, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Ureteral Access Sheath Ureteral Access Sheath With Suction Collection Stone Retrieval Basket DIS8000 Image Processor Medical Video Endoscope URS3005, URS3006, URS3016, URS3005E, URS3006E, URS3016E Single-Use Grasping Forceps Single-Use Biopsy Forceps

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FED Endoscopic Access Overtube, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2025-04-10
FFL Dislodger, Stone, Basket, Ureteral, Metal Gastroenterology, Urology Class 2 876.4680 2025-12-02
FGB Ureteroscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2025-08-27
PTS Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt Gastroenterology, Urology Class 2 876.1500 2026-04-10
EFW Toothbrush, Manual Dental Class 1 872.6855 2025-01-12

Official Correspondent

Vince Zeng

US Agent Details

Linda Chen Business: Dynasty Medical Consulting Inc. Email: usagent@chonconn.com Phone: (832) 3809688

Related Public Records

Same Entity

SEPLOU (ZHUHAI) CO.,LTD.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K230752 FUJIFILM Healthcare Americas Corporation Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A) 2023-09-15
K915458 Psi Medical Products, Inc. URETEROSCOPE 1992-01-30
K973236 Procter & Gamble Co. CREST TOOTHBRUSH WITH MICROSHIELD 1998-03-11

Similar Registrations

Registration Number Establishment Name Location
3044858680 JIENO YOUCHENG MEDICAL TECHNOLOGY (SHANGHAI) CO., LTD. Shanghai, CN
3030511423 ZHEJIANG YIGAO MEDICAL TECHNOLOGY CO., LTD. Hangzhou Zhejiang, CN
3011050570 Gyrus ACMI, Inc. Brooklyn Park, MN, US
3012345110 Novadaq Technologies ULC Burnaby British Columbia, CA
3032959393 CALYXO, INC. Pleasanton, CA, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3035480112. Last updated year: 2026. Please use registration number 3035480112 when referencing this establishment in official correspondence.
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