Data / Medical devices / Taiwan / HMD Biomedical, Inc.
HMD Biomedical, Inc.: FDA-registered device maker in Hsinchu County Hsinchu(County), Taiwan, 8 510(k) clearances
HMD Biomedical, Inc. is registered with the FDA (registration 3003902721) in Hsinchu County Hsinchu(County), Taiwan. It lists 12 device types. The FDA files 8 510(k) clearances under its listings, the newest dated August 29, 2022. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3003902721
- Address
- No 181 Minsheng St, Xinpu Township, Hsinchu County Hsinchu(County), Taiwan, 305
- Owner or operator
- GL DIABETES CORPORATION (9053177)
- Roles
- Contract manufacturer, Exporter to the US, Foreign private label distributor, Manufacturer, Repackager or relabeler
- First device listed
- December 6, 2007
- Registered through
- 2027
- Brand names listed
- Cucare copper socks, Easy@Home Blood Glucose Test Strip, Easy@Home EBG-100BLE Blood Glucose Monitoring System, Easy@Home blood glucose monitoring system, FIA Biomed Blood Glucose Monitoring System GV-01, FIA Biomed Precisa Blood Glucose Monitoring System, FIA Biomed Salut Blood Glucose Monitoring System, FIA Biomed Salut Professional Blood Glucose Monitoring System and more
Devices it lists
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 |
|---|---|---|---|---|---|---|
| August 29, 2022 | K212248 | GlucoLeader Enhance 2 Blood Glucose Monitoring System | NBW | Substantially Equivalent | Hmd Biomedical, Inc. | accessdata.fda.gov |
| May 8, 2019 | K182428 | GlucoLeader Enhance Blood Glucose Monitoring System | NBW | Substantially Equivalent | Hmd Biomedical, Inc. | accessdata.fda.gov |
| May 14, 2015 | K140150 | Goodlife AC-300 Blood Glucose Monitoring System, Goodlife AC-301 Blood Glucose Monitoring System, Goodlife AC-302 Blood Glucose Monitoring System, Goodlife AC 303 Blood Glucose Monitoring System, Goodlife AC-304 Blood Glucose Monitoring System Goodlife AC-305 Blood Glucose Monitoring System, Goodlife AC-300 Professional Blood Glucose Monitoring System, Goodlife AC-301 Professional Blood Glucose Monitoring System Goodlife AC-30 | NBW | Substantially Equivalent | Hmd Biomedical, Inc. | accessdata.fda.gov |
| September 18, 2014 | K131173 | FIA Blood Glucose Monitoring System (G2) | NBW | Substantially Equivalent | Hmd Biomedical, Inc. | accessdata.fda.gov |
| February 14, 2013 | K121433 | GOODLIFE CS-200 (SINGLE PATIENT USE), CS-200 PROFESSIONAL (MULTIPLE PATIENT USE) BLOOD GLUCOSE MONITORING SYSTEMS | LFR | Substantially Equivalent | Hmd Biomedical, Inc. | accessdata.fda.gov |
| September 5, 2012 | K120064 | TEST, BLOOD GLUCOSE SYSTEM | NBW | Substantially Equivalent | Hmd Biomedical, Inc. | accessdata.fda.gov |
| July 27, 2012 | K113307 | GL GOODLIFE SERIES BLOOD GLUCOSE MONITORING SYSMTEM | LFR | Substantially Equivalent | Hmd Biomedical, Inc. | accessdata.fda.gov |
| October 21, 2003 | K032985 | GLUCOLEADER ENHANCE SELF-MONITORING OF BLOOD GLUCOSE SYSTEM | NBW | Substantially Equivalent | Hmd Biomedical, Inc. | accessdata.fda.gov |
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Updated August 29, 2022. 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.