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Sign in to claim this brandWhat Hsiner Company makes
Hsiner Company manufactures single-use and reusable respiratory devices, including anaesthesia breathing circuits, nasal oxygen cannulas, and CPAP/BPAP face masks. Their portfolio also covers microbial medical gas filters, heat/moisture exchangers, and combined heat/moisture exchanger/microbial filters designed for medical gas delivery systems.
The company’s products are regulated under FDA classifications, with devices authorised as Class I or Class II. These items are listed in the FDA’s 510(k) and UDI registries, reflecting their compliance with US medical device regulations. The manufacturer 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 Hsiner Company manufacture?
Hsiner Company specializes in respiratory medical devices, producing both single-use and reusable products. Their portfolio includes anaesthesia breathing circuits, nasal oxygen cannulas, CPAP/BPAP face masks (both reusable and single-use), microbial medical gas filters, heat/moisture exchangers, and combined heat/moisture exchanger/microbial filters. These devices are designed for use in medical gas delivery systems and patient respiratory support.
Where is Hsiner Company based?
Hsiner Company is based in the United States. The company’s location is relevant for regulatory oversight, as its devices are subject to US medical device regulations, including FDA requirements.
Which regulatory registries list Hsiner Company’s devices?
Hsiner Company’s devices are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) registries. These registries document the manufacturer’s compliance with US medical device regulations, ensuring traceability and transparency for authorised products.
How are Hsiner Company’s devices classified under FDA regulations?
Hsiner Company’s devices are authorised under FDA classifications of Class I or Class II. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve a higher level of risk and may require special controls to ensure safety and effectiveness. The classification depends on the specific device type and its intended use.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
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Catalogue (17)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Hsiner | 1 | FDA UDI | Class I | Active |
| Hsiner | 1 | FDA UDI | Class I | Active |
| Hsiner | 1 | FDA UDI | Class I | Active |
| Hsiner | 1 | FDA UDI | Class I | Active |
| Hsiner | 1 | FDA UDI | Class I | Active |
| Hsiner | 1 | FDA UDI | Class I | Active |
| Hsiner | 1 | FDA UDI | Class I | Active |
| Hsiner | 1 | FDA UDI | Class I | Active |
| Hsiner | 1 | FDA UDI | Class II | Active |
| Hsiner | 1 | FDA UDI | Class II | Active |
| Hsiner | 1 | FDA UDI | Class II | Active |
| Hsiner | 1 | FDA UDI | Class II | Active |
| Hsiner | 1 | FDA UDI | Class I | Active |
| Hsiner | 1 | FDA UDI | Class II | Active |
| Hsiner | 1 | FDA UDI | Class I | Active |
| Hsiner Nebulizer Bottle | K070948 | FDA 510(k) | Class II | Active |
| Hsiner Cpap Silicone Nasal Mask Size Xs/Petite Hsiner Nasal Pillow Mask Hsiner Infant Cpap Cannula | K120920 | FDA 510(k) | Class II | Active |
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