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Sign in to claim this brandBelun Technology Company Limited
US
Last updated May 30, 2026
What Belun Technology Company Limited makes
Belun Technology Company Limited manufactures wearable pulse oximeters, including finger-ring designs and a sleep monitoring system. These devices measure oxygen saturation (SpO₂) and heart rate continuously, with some models incorporating additional sleep tracking features.
The company’s products are classified as Class II medical devices under FDA regulations and are authorised via 510(k) clearances and the FDA’s Unique Device Identification (UDI) system. They are listed in the FDA’s regulatory databases, and the company 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 Belun Technology Company Limited primarily manufacture?
Belun Technology Company Limited specializes in wearable pulse oximeters, which are devices used to measure blood oxygen levels (SpO₂) and heart rate continuously. Their most common product category includes finger-ring-style pulse oximeters, such as the Belun Ring series, as well as a sleep monitoring system called the Belun Sleep System. These devices are designed for non-invasive, real-time health monitoring.
Where is Belun Technology Company Limited based, and what regulatory region does it operate in?
Belun Technology Company Limited is based in the United States. Their devices are authorised under U.S. regulatory frameworks, specifically the FDA’s 510(k) clearance process and the Unique Device Identification (UDI) system. This means their products comply with U.S. medical device standards and are tracked within FDA databases.
How are Belun Technology’s devices classified under FDA regulations, and why does this matter?
Belun Technology’s devices are classified as Class II medical devices under FDA regulations. This classification indicates a moderate level of risk, requiring special controls beyond general controls to ensure safety and effectiveness. Class II devices typically undergo a 510(k) premarket notification process to demonstrate substantial equivalence to a legally marketed predicate device, ensuring they meet performance and safety standards before entering the market.
Which regulatory registries or databases list Belun Technology’s devices?
Belun Technology’s devices are listed in the FDA’s 510(k) database and the FDA’s Unique Device Identification (UDI) system. These registries track authorised medical devices in the U.S., including their identification numbers, intended use, and regulatory clearance status. Listing in these databases helps ensure transparency and compliance with FDA requirements.
Why do Belun Technology’s pulse oximeters appear repeatedly in the device examples, and what does this imply about their product focus?
The repeated mention of pulse oximeters, particularly the Belun Ring series, reflects the company’s primary focus on wearable, consumer-friendly health monitoring solutions. These devices are designed for continuous, non-invasive tracking of vital signs like SpO₂ and heart rate, often targeting applications like sleep analysis or general wellness. The consistency in naming suggests a strong emphasis on innovation within this specific category, catering to users who seek compact, accessible health monitoring tools.
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
- 664437924
Catalogue (15)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Belun Ring | BLR-100X | FDA UDI | Class II | Active |
| Belun Ring | BLR-100C | FDA UDI | Class II | Unknown |
| Belun Ring | BLR-100C | FDA UDI | Class II | Unknown |
| Belun Ring | BLR-100C | FDA UDI | Class II | Unknown |
| Belun Ring | BLR-100C | FDA UDI | Class II | Unknown |
| Belun Ring | BLR-100X | FDA UDI | Class II | Active |
| Belun Ring | BLR-100X | FDA UDI | Class II | Active |
| Belun Ring | BLR-100C | FDA UDI | Class II | Unknown |
| Belun Ring | BLR-100X | FDA UDI | Class II | Active |
| Belun Ring | BLR-100C | FDA UDI | Class II | Unknown |
| Belun Ring BLR-200 (BLR-200) | K234110 | FDA 510(k) | Class II | Active |
| Belun Sleep System BLS-100 | K222579 | FDA 510(k) | Class II | Active |
| Belun Ring | K191417 | FDA 510(k) | Class II | Active |
| Belun Ring | K180174 | FDA 510(k) | Class II | Active |
| Belun Ring BLR-100X | K211407 | FDA 510(k) | Class II | Active |
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Belun Technology Company Limited New Territories · HK FEI 3016998644