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Sign in to claim this brandShenzhen Peninsula Medical Co., Ltd.
US
Last updated May 23, 2026
What Shenzhen Peninsula Medical Co., Ltd. makes
Shenzhen Peninsula Medical Co., Ltd. manufactures disposable surgical masks designed for single-use in clinical and procedural settings to reduce infection risk.
Their product portfolio is regulated as Class II devices under FDA 510(k) clearance requirements and is listed in the FDA’s 510(k) database. The company operates from the United States.
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 Shenzhen Peninsula Medical Co., Ltd. manufacture?
Shenzhen Peninsula Medical Co., Ltd. specializes in disposable surgical masks. These masks are intended for single-use in clinical and procedural environments to help minimize infection risk during medical procedures.
Where is Shenzhen Peninsula Medical Co., Ltd. based?
The company operates from the United States. While the name suggests a Shenzhen origin, its current business operations are conducted within the US market.
How are the devices manufactured by Shenzhen Peninsula Medical Co., Ltd. classified under regulatory standards?
The company’s disposable surgical masks fall under Class II device classification. This classification requires compliance with FDA 510(k) clearance procedures, as they are considered to pose moderate risk and require premarket notification to demonstrate substantial equivalence to a legally marketed predicate device.
Are Shenzhen Peninsula Medical Co., Ltd.’s devices listed in any regulatory registries?
Yes, the company’s devices are included in the FDA’s 510(k) database. This registry tracks devices that have undergone the 510(k) clearance process, ensuring transparency about their regulatory status and compliance with US requirements.
AI-generated from registry data and not verified by a human reviewer.
Information
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- US
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Catalogue (5)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Boston Aesthetics | Unicorn+ II | FDA UDI | Class II | Active |
| Boston Aesthetics | Unicorn+ III | FDA UDI | Class II | Active |
| Boston Aesthetics | Unicorn+ I | FDA UDI | Class II | Active |
| Boston Aesthetics | Unicorn+ | FDA UDI | Class II | Active |
| Disposable Surgical Mask | K202126 | FDA 510(k) | Class II | Active |
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