Belun Ring
Belun Ring is a finger-worn pulse oximeter that records oxygen saturation and pulse rate. Red and infrared light illuminate the skin, and the device calculates oxygen saturation from the…
Belun Ring is a finger-worn pulse oximeter that records oxygen saturation and pulse rate. Red and infrared light illuminate the skin, and the device calculates oxygen saturation from the relative absorption of the two wavelengths.
The ring records independently during use, with a changeable soft ring arm to fit the finger. A separate cradle charges the ring and collects the recorded data.
Listed Item
Belun Ring BLR-100X Size U
Data Transfer and Display
The cradle transfers data to the host programme through USB or Bluetooth, and the software presents text or graphical results. The system is intended for adult index-finger recordings in hospital or home settings for up to ten hours and does not provide alarms.
Who Else Makes It
Concentrated in Guangdong (46), Jiangsu (7), Beijing (5). 10 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Tianjin Choice Medical Device Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 12 |
| Taijia Medical Electronics (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 10 |
| EMI (Dongguan) Asia Limited | Dongguan | Guangdong | Contract manufacturer | 9 |
| Wuhan Strong Electronics | Wuhan | Hubei | Contract manufacturer | 6 |
| Regent Electron Suzhou Co., Ltd. | Wujiang | Jiangsu | Contract manufacturer | 5 |
| Dongguan Ruibaolian Medical Science & Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 4 |
| Dongguan Kepler Special Cabling Company Limited | Dongguan | Guangdong | Contract manufacturer | 3 |
| Measurement Specialties Chengdu | Chengdu | Sichuan | Contract manufacturer | 3 |
| Beijing Kingst Commercial & Trade Co., Ltd. | Beijing | Beijing | Contract manufacturer | 2 |
| Suzhou Meccan Import and Export Corp. | Suzhou | Jiangsu | Contract manufacturer | 71 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
Showing 12 of 70. All 70 manufacturers in China registered for Oximeter
Record
| Listed by | Belun Technology Company Limited, Hong Kong |
|---|---|
| FDA product code | DQA |
| Device type | Oximeter |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2700 |
| Establishment | Manufacturer |
| 510(k) | K211407 |
| Record published | 2020-12-31 |
| Record revised | 2024-06-13 (version 4) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
| Distribution end date | 2021-11-30 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| BLR-100X | In distribution | |
| BLR-100X | In distribution | |
| BLR-100X | In distribution | |
| BLR-100X | In distribution | |
| BLR-100X | In distribution | |
| BLR-100C | Withdrawn | |
| BLR-100C | Withdrawn | |
| BLR-100C | Withdrawn | |
| BLR-100C | Withdrawn | |
| BLR-100C | Withdrawn | |
| BLR-100C | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Unimed | Unimed Medical Supplies Inc | 2,838 |
| APK | APK Technology Co., Ltd. | 2,678 |
| ChoiceMMed | Beijing Choice Electronic Technology Co., Ltd. | 151 |
| Nellcor | Covidien LP | 138 |
| Nonin | Nonin Medical, Inc. | 129 |
| Orantech | Orantech Inc. | 97 |
| Med-link | Shenzhen MED-Link Electronics Tech Co., Ltd. | 93 |
| Welch Allyn, Inc. | Welch Allyn, Inc. | 66 |
| Medichoice | Owens & Minor Distribution, Inc. | 62 |
| Caremed | Shenzhen Caremed Medical Technology Co., Ltd. | 55 |
| Sensoronics | Sensoronics Incorporated | 53 |
| Virtuox | Healthcare Logistics Systems | 36 |
Showing 12 of 1,063. All products under Oximeter
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K234110 | 2024-10-11 |
| K211407 | 2021-10-21 |
| K191417 | 2019-10-10 |
| K180174 | 2018-05-29 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.