Data / Medical devices / Hong Kong / Belun Technology Company Limited
Belun Technology Company Limited: FDA-registered device maker in New Territories, Hong Kong, 2 510(k) clearances
Belun Technology Company Limited is registered with the FDA (registration 3016998644) in New Territories, Hong Kong. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated February 23, 2023. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3016998644
- Address
- Flat 47, 15/F., Block F, Wah Lok Industrial Centre 31-41 Shan Mei Street, Fotan, New Territories, Hong Kong, 00000000
- Owner or operator
- Belun Technology Company Limited (10069714)
- Roles
- Manufacturer
- First device listed
- April 11, 2022
- Registered through
- 2026
- Brand names listed
- Belun Ring, Belun Sleep System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Oximeter | DQA | 2 | Manufacturer | accessdata.fda.gov |
| Ventilatory Effort Recorder | MNR | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 23, 2023 | K222579 | Belun Sleep System BLS-100 | MNR | Substantially Equivalent | Belun Technology Company Limited | accessdata.fda.gov |
| October 21, 2021 | K211407 | Belun Ring BLR-100X | DQA | Substantially Equivalent | Belun Technology Company Limited | accessdata.fda.gov |
Compare with other makers
Updated February 23, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.