Seplou (Zhuhai) Co., Ltd.
Manufacturer and brand owner in Zhuhai, Guangdong, China. 7 device types, 6 products catalogued, 2 clearances.
Seplou (Zhuhai) Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Dilator, Urethral, Toothbrush, Manual and 5 other device types. 6 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2025.
7device types registered with the FDA
6products catalogued under its own name
2510(k) clearances
Registration
| Registered name | SEPLOU (ZHUHAI) CO.,LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3035480112 |
| FEI number | 3035480112 |
| DUNS | 847378548 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 斯普乐（珠海）生物科技有限责任公司 |
|---|---|
| Unified social credit code | 91440400MABUTQYMX1 |
| Source | export sales certificate, Guangdong medical products administration |
Location
| City | Zhuhai |
|---|---|
| Province | Guangdong |
| Address | 5th Floor, Building 1, No. 8, Keji 10th Road, Tangjiawan Town, High-tech Zone |
| Postal code | 519085 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Bottle, Collection, Vacuum | Class 2 | Stone Collection Bottle | 2025 | 88 |
| Dilator, Urethral | Class 2 | Urethral Dilator | 2026 | 4 |
| Dislodger, Stone, Basket, Ureteral, Metal | Class 2 | Stone Retrieval Basket | 2025 | 21 |
| Endoscopic Access Overtube, Gastroenterology-Urology | Class 2 | Ureteral Access Sheath, Ureteral Access Sheath With Suction Collection, Ureteral Aspiration Device with Collection Canister | 2025 | 19 |
| Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt | Class 2 | Single-Use Grasping Forceps, Single-Use Biopsy Forceps | 2026 | 21 |
| Toothbrush, Manual | Class 1 | 2025 | 244 | |
| Ureteroscope And Accessories, Flexible/Rigid | Class 2 | Image Processor, DIS8000, URS3005, URS3006, URS3016, URS3005E, URS3006E, URS3016E, Medical Video Endoscope | 2025 | 21 |
Own-Brand Listings
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K250049 | 2025-08-26 | FGB | Traditional | This company |
| K243025 | 2025-01-30 | FED | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Main products | Urological surgical devices, Flexible ureteroscopes, Urology equipment |
|---|
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.