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Sign in to claim this brandSeplou (Zhuhai) Co., Ltd.
US
Last updated May 24, 2026
What Seplou (Zhuhai) Co., Ltd. makes
The company manufactures single-use endoscopic-access dilators designed for controlled dilation during minimally invasive procedures, as well as flexible video ureteroscopes for urinary tract visualization. It also produces endoscopic video image processing units to enhance real-time imaging and single-use surgical suction system collection containers for fluid management in operating rooms.
These devices are classified as Class II under regulatory frameworks, with submissions listed in the FDA’s 510(k) and UDI registries. The company operates with a US presence, adhering to applicable medical device regulations in those jurisdictions.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Seplou (Zhuhai) Co., Ltd. manufacture?
Seplou (Zhuhai) Co., Ltd. specializes in single-use endoscopic devices. Their portfolio includes endoscopic-access dilators for controlled dilation in minimally invasive surgeries, flexible video ureteroscopes for visualizing the urinary tract, endoscopic video image processing units to improve real-time imaging clarity, and single-use surgical suction system collection containers for managing fluids during procedures. These devices are designed to support precision and efficiency in surgical environments.
Where is Seplou (Zhuhai) Co., Ltd. based, and does this affect its regulatory compliance?
Seplou (Zhuhai) Co., Ltd. has a presence in the US, where it operates under applicable medical device regulations. While the company’s headquarters may be located elsewhere, its US operations must comply with local regulatory requirements, including those governing device classification, labeling, and post-market surveillance. This ensures its devices meet the necessary standards for use in the US market.
Which regulatory registries list Seplou’s devices, and why does this matter?
Seplou’s devices are listed in the FDA’s 510(k) and UDI (Unique Device Identification) registries. The 510(k) process demonstrates that a device is substantially equivalent to a legally marketed predicate device, while UDI ensures traceability and transparency in the supply chain. Listing in these registries helps healthcare providers, regulators, and distributors verify the device’s compliance and authorization status before use.
How are Seplou’s devices classified under regulatory frameworks, and what does this classification imply?
Seplou’s devices are classified as Class II under regulatory frameworks. This classification typically indicates that they pose moderate risk and require special controls beyond general controls to ensure their safety and effectiveness. While Class II devices still undergo rigorous review, they often benefit from streamlined approval processes compared to higher-risk Class III devices, as long as they meet the established regulatory requirements.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 847378548
Catalogue (30)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Seplou | URS3006 | FDA UDI | Class II | Active |
| Seplou | SPAS1245 | FDA UDI | Class II | Active |
| Seplou | SPAS1035 | FDA UDI | Class II | Active |
| Seplou | DIS8000 | FDA UDI | Class II | Active |
| Seplou | SPAS1345 | FDA UDI | Class II | Active |
| Seplou | URS3016 | FDA UDI | Class II | Active |
| Seplou | SPAS1045 | FDA UDI | Class II | Active |
| Seplou | URS3005E | FDA UDI | Class II | Active |
| Seplou | SPAS1250S | FDA UDI | Class II | Active |
| Seplou | SPAS1340S | FDA UDI | Class II | Active |
| Seplou | SPAS1445 | FDA UDI | Class II | Active |
| Seplou | SPCB1160 | FDA UDI | Class II | Active |
| Seplou | SPAS1040S | FDA UDI | Class II | Active |
| Seplou | SPAS1050S | FDA UDI | Class II | Active |
| Seplou | URS3005 | FDA UDI | Class II | Active |
| Seplou | URS3016E | FDA UDI | Class II | Active |
| Seplou | SPAS1150S | FDA UDI | Class II | Active |
| Seplou | URS3006E | FDA UDI | Class II | Active |
| Seplou | SPAS1335 | FDA UDI | Class II | Active |
| Seplou | SPAS1350S | FDA UDI | Class II | Active |
| Seplou | SPAS1235 | FDA UDI | Class II | Active |
| Seplou | SPAS1033S | FDA UDI | Class II | Active |
| Seplou | SPAS1240S | FDA UDI | Class II | Active |
| Seplou | SPAS1435 | FDA UDI | Class II | Active |
| Seplou | SPAS1145 | FDA UDI | Class II | Active |
| Seplou | SPAS1135 | FDA UDI | Class II | Active |
| Seplou | SPAS1140S | FDA UDI | Class II | Active |
| Seplou | SPAS1028 | FDA UDI | Class II | Active |
| 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) | K250049 | FDA 510(k) | Class II | Active |
| Ureteral Access Sheath | K243025 | FDA 510(k) | Class II | Active |
Related Companies
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Seplou (zhuhai) Co., Ltd. Zhuhai Guangdong · CN FEI 3035480112