Data / Medical devices / Hong Kong / Beurer Far East Ltd.
Beurer Far East Ltd.: FDA-registered device maker in Hong Kong SAR, Hong Kong, 10 510(k) clearances
Beurer Far East Ltd. is registered with the FDA (registration 3012134907) in Hong Kong SAR, Hong Kong. It lists 9 device types. The FDA files 10 510(k) clearances under its listings, the newest dated April 8, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012134907
- Address
- Unit 1501, 15 Floor 118 Connaught Road west, Hong Kong SAR, Hong Kong, 0000
- Owner or operator
- Beurer Far East Ltd. (10094506)
- Roles
- Complaint file establishment, Exporter to the US, Foreign private label distributor
- First device listed
- December 4, 2025
- Registered through
- 2026
- Brand names listed
- BC33, BC43, BM22, BM22/1, BM25, BM26, BM27, BM31 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Blood Pressure Cuff | DXQ | 2 | Exporter to the US | accessdata.fda.gov |
| Continuous Measurement Thermometer | FLL | 2 | Foreign private label distributor | accessdata.fda.gov |
| Electrode, Cutaneous | GXY | 2 | Exporter to the US | accessdata.fda.gov |
| Humidifier, Non-Direct Patient Interface (Home-Use) | KFZ | 1 | Exporter to the US, Foreign private label distributor | accessdata.fda.gov |
| Media, Electroconductive | GYB | 2 | Exporter to the US | accessdata.fda.gov |
| Stimulator, Muscle, Powered, For Muscle Conditioning | NGX | 2 | Exporter to the US | accessdata.fda.gov |
| Stimulator, Nerve, Transcutaneous, Over-The-Counter | NUH | 2 | Exporter to the US | accessdata.fda.gov |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | 2 | Complaint file establishment, Exporter to the US, Foreign private label distributor | accessdata.fda.gov |
| Unit, Oral Irrigation | EFS | 1 | Exporter to the US, Foreign private label distributor | 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 |
|---|---|---|---|---|---|---|
| April 8, 2025 | K250136 | Globalcare Blood Pressure Monitor (GUS610) | DXN | Substantially Equivalent | Globalcare Medical Technology Co., Ltd. | accessdata.fda.gov |
| December 17, 2024 | K242815 | POCKET TENS (EP-300) | NUH | Substantially Equivalent | Hivox Biotek, Inc. | accessdata.fda.gov |
| November 22, 2022 | K222160 | GUS610 Blood pressure monitor | DXN | Substantially Equivalent | Globalcare Medical Technology Co., Ltd. | accessdata.fda.gov |
| October 15, 2021 | K211403 | HIVOX OTC Electrical Stimulator, FT610-B | NUH | Substantially Equivalent | Hivox Biotek, Inc. | accessdata.fda.gov |
| March 10, 2021 | K203574 | HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical Stimulator, EM59-2 | NUH | Substantially Equivalent | Hivox Biotek, Inc. | accessdata.fda.gov |
| March 15, 2019 | K190347 | HIVOX OTC Electrical Stimulator | NUH | Substantially Equivalent | Hivox Biotek, Inc. | accessdata.fda.gov |
| November 29, 2017 | K171803 | HIVOX OTC Electrical Stimulator | NUH | Substantially Equivalent | Hivox Biotek, Inc. | accessdata.fda.gov |
| September 8, 2015 | K151460 | Fully Automatic Electronic Blood Pressure Monitor | DXN | Substantially Equivalent | Andon Health Co, Ltd. | accessdata.fda.gov |
| April 29, 2015 | K141984 | FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR | DXN | Substantially Equivalent | Andon Health Co, Ltd. | accessdata.fda.gov |
| July 25, 2014 | K131720 | HIVOX SELF ADHESIVE ELECTRODE GEL PADS | GXY | Substantially Equivalent | Hivox Biotek, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Measurement, Blood-Pressure, Non-Invasive
- All makers of Electrode, Cutaneous
- All makers of Media, Electroconductive
- All makers of Continuous Measurement Thermometer
- All makers of Unit, Oral Irrigation
- All makers of Stimulator, Nerve, Transcutaneous, Over-The-Counter
Updated April 8, 2025. 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.