Data / Medical devices / China / Seplou (zhuhai) Co.,ltd.
Seplou (zhuhai) Co.,ltd.: FDA-registered device maker in Zhuhai Guangdong, China, 2 510(k) clearances
Seplou (zhuhai) Co.,ltd. is registered with the FDA (registration 3035480112) in Zhuhai Guangdong, China. It lists 7 device types. The FDA files 2 510(k) clearances under its listings, the newest dated August 26, 2025. Registered through 2027. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3035480112
- Address
- 5th Floor, Building 1, No. 8, Keji 10th Road, Tangjiawan Town, High-tech Zone, Zhuhai Guangdong, China, 519085
- Owner or operator
- SEPLOU (ZHUHAI) CO.,LTD. (10092239)
- Roles
- Manufacturer
- First device listed
- January 12, 2025
- Registered through
- 2027
- Brand names listed
- DIS8000, Image Processor, Medical Video Endoscope, Single-Use Biopsy Forceps, Single-Use Grasping Forceps, Stone Collection Bottle, Stone Retrieval Basket, URS3005, URS3006, URS3016, URS3005E, URS3006E, URS3016E and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bottle, Collection, Vacuum | KDQ | 2 | Manufacturer | accessdata.fda.gov |
| Dilator, Urethral | KOE | 2 | Manufacturer | accessdata.fda.gov |
| Dislodger, Stone, Basket, Ureteral, Metal | FFL | 2 | Manufacturer | accessdata.fda.gov |
| Endoscopic Access Overtube, Gastroenterology-Urology | FED | 2 | Manufacturer | accessdata.fda.gov |
| Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt | PTS | 2 | Manufacturer | accessdata.fda.gov |
| Toothbrush, Manual | EFW | 1 | Manufacturer | accessdata.fda.gov |
| Ureteroscope And Accessories, Flexible/Rigid | FGB | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 26, 2025 | K250049 | Medical 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) | FGB | Substantially Equivalent | Seplou (Zhuhai) Co., Ltd. | accessdata.fda.gov |
| January 30, 2025 | K243025 | Ureteral Access Sheath | FED | Substantially Equivalent | Seplou (Zhuhai) Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Toothbrush, Manual
- All makers of Dilator, Urethral
- All makers of Bottle, Collection, Vacuum
- All makers of Ureteroscope And Accessories, Flexible/Rigid
- All makers of Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt
- All makers of Dislodger, Stone, Basket, Ureteral, Metal
Updated August 26, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.