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Sign in to claim this brandHeadstar Medical Products Co., Ltd.
US
Last updated May 23, 2026
What Headstar Medical Products Co., Ltd. makes
Headstar Medical Products Co., Ltd. manufactures reusable cardiopulmonary resuscitation masks, single-use and reusable manual pulmonary resuscitators, nebulizing system delivery sets, tracheostomy and Venturi oxygen masks, and oxygen administration tubing. Their portfolio also includes non-powered airway pressure monitors designed for respiratory support applications.
The company’s devices are classified under FDA regulations as Class I and Class II, with submissions recorded in the 510(k) and UDI registries. Headstar Medical Products Co., Ltd. is based in 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 Headstar Medical Products Co., Ltd. manufacture?
Headstar Medical Products Co., Ltd. specializes in devices for respiratory and emergency care. Their portfolio includes reusable cardiopulmonary resuscitation (CPR) masks, single-use and reusable manual pulmonary resuscitators, nebulizing system delivery sets, tracheostomy masks, Venturi oxygen face masks, oxygen administration tubing, and non-powered airway pressure monitors. These products are designed to support respiratory function and emergency interventions.
Where is Headstar Medical Products Co., Ltd. based?
Headstar Medical Products Co., Ltd. is headquartered in the United States. The company’s location is relevant for regulatory submissions and compliance, as it operates under U.S. medical device regulations.
Which regulatory registries list Headstar Medical Products Co., Ltd.’s devices?
Headstar Medical Products Co., Ltd.’s devices are recorded in the FDA’s 510(k) premarket notification registry and the Unique Device Identifier (UDI) database. These registries track submissions for regulatory oversight, ensuring compliance with U.S. medical device requirements.
How are Headstar Medical Products Co., Ltd.’s devices classified under FDA regulations?
Headstar Medical Products Co., Ltd.’s devices fall under Class I and Class II classifications under FDA regulations. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve a higher risk and may require special controls or performance standards. The classification determines the regulatory pathway and submission requirements for each device.
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
- 658122049
Catalogue (25)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Headstar | HS-8801 | FDA UDI | Class I | Active |
| Headstar | HP93111A-3U | FDA UDI | Class II | Active |
| Headstar | HS-8805P | FDA UDI | Class I | Active |
| Headstar | HS-8803P | FDA UDI | Class I | Active |
| Headstar | HS-8805 | FDA UDI | Class I | Active |
| Headstar | HP-8609 | FDA UDI | Class I | Active |
| Headstar | HS-8804P | FDA UDI | Class I | Active |
| Headstar | HP93111I-3U | FDA UDI | Class II | Active |
| Headstar | HP-8509 | FDA UDI | Class I | Active |
| Headstar | HS-9212 | FDA UDI | Class I | Active |
| Headstar | HP-2558 | FDA UDI | Class II | Active |
| Headstar | HP-8608 | FDA UDI | Class I | Active |
| Headstar | HS-8803 | FDA UDI | Class I | Active |
| Headstar | HP-2557 | FDA UDI | Class II | Active |
| Headstar | HP-2558 | FDA UDI | Class II | Active |
| Headstar | HP-1108-7E | FDA UDI | Class I | Active |
| Headstar | HS-8804 | FDA UDI | Class I | Active |
| Headstar | HS-8802 | FDA UDI | Class I | Active |
| Headstar | HP-2557 | FDA UDI | Class II | Active |
| Headstar | HS-8800 | FDA UDI | Class I | Active |
| Headstar | HP93111C-3U | FDA UDI | Class II | Active |
| Headstar | HP-8508 | FDA UDI | Class I | Active |
| Headstar | HS-9288AP | FDA UDI | Class II | Active |
| Headstar's Manual Emergency Resuscitator | K002846 | FDA 510(k) | Class II | Active |
| Headstar Medical Small Volume Jet Nebulizer | K121770 | 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.
- Headstar Medical Products Co., Ltd NEW TAIPEI CITY · TW FEI 3003418980