Data / Medical devices / Taiwan / Eps Bio Technology Corp.
Eps Bio Technology Corp.: FDA-registered device maker in Hsinchu Hsinchu(County), Taiwan, 9 510(k) clearances
Eps Bio Technology Corp. is registered with the FDA (registration 3004130086) in Hsinchu Hsinchu(County), Taiwan. It lists 7 device types. The FDA files 9 510(k) clearances under its listings, the newest dated November 30, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004130086
- Address
- No. 8, R&D Rd. III, Hsinchu Science Park, Hsinchu Hsinchu(County), Taiwan, 30076
- Owner or operator
- EPS BIO TECHNOLOGY CORP. (9058147)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- October 20, 2008
- Registered through
- 2026
- Brand names listed
- BeSmart 2IN1 Self Monitoring Blood Glucose System, BeSure Self Monitoring Blood Glucose System, EASYMAX T1, EMV3.1 Pro Blood glucose System, EMV3.1 Self Monitoring Blood Glucose System, EasyMax, EasyMax 15, EasyMax LTC and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Glucose Dehydrogenase, Glucose | LFR | 2 | Manufacturer | accessdata.fda.gov |
| Glucose Oxidase, Glucose | CGA | 2 | Manufacturer | accessdata.fda.gov |
| Multi-Analyte Controls, All Kinds (Assayed) | JJY | 1 | Manufacturer | accessdata.fda.gov |
| Multiple Use Blood Lancet For Single Patient Use Only | QRL | 2 | Exporter to the US | accessdata.fda.gov |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | 1 | Manufacturer | accessdata.fda.gov |
| Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature | QRK | 2 | Exporter to the US | accessdata.fda.gov |
| System, Test, Blood Glucose, Over The Counter | NBW | 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 |
|---|---|---|---|---|---|---|
| November 30, 2022 | K222472 | Lancing System, Sterile Lancet for Single Use, Lancing Device | QRL | Substantially Equivalent | Shandong Lianfa Medical Plastic Products Co. , Ltd. | accessdata.fda.gov |
| February 27, 2014 | K133647 | EMV3.1 PRO BLOOD GLUCOSE SYSTEM AND EMV3.1 SELF MONITORING BLOOD GLUCOSE SYSTEM | NBW | Substantially Equivalent | Eps Bio Technology Corp. | accessdata.fda.gov |
| May 18, 2012 | K121207 | EASYMAX MU SELF MONITORING BLOOD GLUCOSE SYSTEM, EASYMAX MU PRO SELF MONITORING BLOOD GLUCOSE SYSTEM | LFR | Substantially Equivalent | Eps Bio Technology Corp. | accessdata.fda.gov |
| December 23, 2011 | K112901 | EME SELF MONITORING BLOOD GLUCOSE SYSTEM, EME PRO SELF MONITORING BLOOD GLUCOSE SYSTEM | LFR | Substantially Equivalent | Eps Bio Technology Corp. | accessdata.fda.gov |
| September 7, 2011 | K112272 | EM44 SELF MONITORING BLOOD GLUCOSE SYSTEM, EM44 PRO SELF MONITORING BLOOD GLUCOSE SYSTEM | LFR | Substantially Equivalent | Eps Bio Technology Corp. | accessdata.fda.gov |
| June 21, 2011 | K102345 | EASYMAX T1 SELF MONITORING BLOOD GLUCOSE SYSTEM, MODEL EPS10042 | NBW | Substantially Equivalent | Eps Bio Technology Corp. | accessdata.fda.gov |
| February 24, 2010 | K092894 | EASYMAX V SELF MONITORING BLOOD GLUCOSE SYSTEM | NBW | Substantially Equivalent | Eps Bio Technology Corp. | accessdata.fda.gov |
| January 23, 2009 | K081796 | EASYPLUS MINI R2N SELF MONITORING GLUCOSE TEST SYSTEM | NBW | Substantially Equivalent | Eps Bio Technology Corp. | accessdata.fda.gov |
| September 17, 2008 | K082121 | EASYMAX SELF MONITORING GLUCOSE TEST SYSTEM, MODEL # EPS08005 | CGA | Substantially Equivalent | Eps Bio Technology Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Test, Blood Glucose, Over The Counter
- All makers of Glucose Oxidase, Glucose
- All makers of Single (Specified) Analyte Controls (Assayed And Unassayed)
- All makers of Multiple Use Blood Lancet For Single Patient Use Only
- All makers of Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature
- All makers of Multi-Analyte Controls, All Kinds (Assayed)
Updated November 30, 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.