Eps Bio Technology Corp.
Hsinchu, TW
EPS BIO TECHNOLOGY CORP. appears in FDA device records in Hsinchu, TW. FDA records list 24 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 24 510(k) clearances for Eps Bio Technology Corp. between 2005 and 2021. The busiest year on record is 2009, with 5. The most recent is 2021, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2005 | 1 |
| 2006 | 1 |
| 2007 | 1 |
| 2008 | 1 |
| 2009 | 5 |
| 2010 | 2 |
| 2011 | 5 |
| 2012 | 2 |
| 2014 | 3 |
| 2018 | 1 |
| 2019 | 1 |
| 2021 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K201258 | EASYMAX Tag Self-Monitoring Blood Glucose System | NBW | Substantially Equivalent | |
| K190189 | MDT2 BLE Self-Monitoring Blood Glucose System | NBW | Substantially Equivalent | |
| K182057 | EasyMax BT Self-Monitoring Blood Glucose System | NBW | Substantially Equivalent | |
| K133537 | EGV1.1 SELF MONITORING BLOOD GLUCOSE SYSTEM AND EGV1.1 PRO MONITORING BLOOD GLUCOSE SYSTEM | LFR | Substantially Equivalent | |
| K133389 | EM40 SELF-MONITORING BLOOD GLUCOSE SYSTEM | NBW | Substantially Equivalent | |
| K133647 | EMV3.1 PRO BLOOD GLUCOSE SYSTEM AND EMV3.1 SELF MONITORING BLOOD GLUCOSE SYSTEM | NBW | Substantially Equivalent | |
| K121207 | EASYMAX MU SELF MONITORING BLOOD GLUCOSE SYSTEM, EASYMAX MU PRO SELF MONITORING BLOOD GLUCOSE SYSTEM | LFR | Substantially Equivalent | |
| K113243 | EM50 SELF MONITORING BLOOD GLUCOSE SYSTEM | LFR | Substantially Equivalent | |
| K112901 | EME SELF MONITORING BLOOD GLUCOSE SYSTEM, EME PRO SELF MONITORING BLOOD GLUCOSE SYSTEM | LFR | Substantially Equivalent | |
| K111728 | EMV3 SELF MONITORING BLOOD GLUCOSE SYSTEM, EMV3 PRO SELF MONITORING BLOOD GLUCOSE SYSTEM | CGA | Substantially Equivalent | |
| K112272 | EM44 SELF MONITORING BLOOD GLUCOSE SYSTEM, EM44 PRO SELF MONITORING BLOOD GLUCOSE SYSTEM | LFR | Substantially Equivalent | |
| K102345 | EASYMAX T1 SELF MONITORING BLOOD GLUCOSE SYSTEM, MODEL EPS10042 | NBW | Substantially Equivalent | |
| K101037 | EG V1 (BL) SELF MONITORING GLUCOSE TEST SYSTEM MODEL: EPS10017 | LFR | Substantially Equivalent | |
| K101457 | EASYPLUS MINI R9N SELF MONITORING BLOOD GLUCOSE SYSTEM MODEL EPS10031 | NBW | Substantially Equivalent | |
| K092894 | EASYMAX V SELF MONITORING BLOOD GLUCOSE SYSTEM | NBW | Substantially Equivalent | |
| K092887 | EASYPLUS MINI MASTERDRIVER SELF MONITORING BLOOD GLUCOSE SYSTEM, MODEL EPS09009 | NBW | Substantially Equivalent | |
| K091481 | EASYPLUS MINI R13N SELF MONITORING BLOOD GLUCOSE SYSTEM | NBW | Substantially Equivalent | |
| K091229 | GLUCOMANAGER DATA MANAGEMENT SOFTWARE | NBW | Substantially Equivalent | |
| K081796 | EASYPLUS MINI R2N SELF MONITORING GLUCOSE TEST SYSTEM | NBW | Substantially Equivalent | |
| K083099 | EASYMAX N SELF MONITORING BLOOD GLUCOSE SYSTEM, MODEL: EPS08008 | NBW | Substantially Equivalent | |
| K082121 | EASYMAX SELF MONITORING GLUCOSE TEST SYSTEM, MODEL # EPS08005 | CGA | Substantially Equivalent | |
| K070053 | EASYPLUS MINI SELF MONITORING GLUCOSE TEST SYSTEM, MODELS R1 AND R2 | NBW | Substantially Equivalent | |
| K061992 | EASYPLUS SELF MONITORING GLUCOSE TEST SYSTEM, MODEL EPS04014 | CGA | Substantially Equivalent | |
| K043245 | EPS EASY PAIN SUPREME SELF MONITORING BLOOD GLUCOSE SYSTEM | CGA | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3004130086 | 3004130086 | EPS BIO TECHNOLOGY CORP. | No. 8, R&D Rd. III, Hsinchu Science Park,, Hsinchu Hsinchu(County) 30076 TW | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- LFRGlucose Dehydrogenase, Glucose
- CGAGlucose Oxidase, Glucose
- JJYMulti-Analyte Controls, All Kinds (Assayed)
- QRLMultiple Use Blood Lancet For Single Patient Use Only
- JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
- QRKSingle Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature
- NBWSystem, Test, Blood Glucose, Over The Counter
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain