# Eps Bio Technology Corp.

- Location (FDA's records): Hsinchu, TW
- FDA decisions: 25 (2005–2026): 25 510(k) clearances
- Names in FDA's records: Eps Bio Technology Corp. (24); EPS Bio Technology Corp. (1)
- Product codes: NBW (15), LFR (6), CGA (4)
- 510(k) review time since 2016: median 230 days, against 179 for FDA's reviews in the same codes and years (2 of 4 faster)
- Predicates its devices cite: 9 (5 its own); citations of its devices by later devices: 5 (5 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Medisense, Inc.: 1 (https://510kreport.com/company/medisense)
- Bayer Healthcare, LLC: 1 (https://510kreport.com/company/bayer-healthcare)
- Lifescan, Inc.: 1 (https://510kreport.com/company/lifescan)
- Roche Diagnostics Corp.: 1 (https://510kreport.com/company/roche-diagnostics)

## Its most-cited devices
- K121207: Easymax MU Self Monitoring Blood Glucose System, Easymax MU Pro Self Monitoring Blood Glucose System (2012), cited by 2
- K043245: Eps Easy Pain Supreme Self Monitoring Blood Glucose System (2005), cited by 1
- K061992: Easyplus Self Monitoring Glucose Test System, Model EPS04014 (2006), cited by 1
- K133389: EM40 Self-Monitoring Blood Glucose System (2014), cited by 1

## Recent decisions
- K261293: EASYMAX Voice Blood Glucose Monitoring System (Oct 23, 2026)
- K201258: EASYMAX Tag Self-Monitoring Blood Glucose System (Sep 1, 2021)
- K190189: MDT2 BLE Self-Monitoring Blood Glucose System (Nov 1, 2019)
- K182057: EasyMax BT Self-Monitoring Blood Glucose System (Aug 24, 2018)
- K133537: EGV1.1 Self Monitoring Blood Glucose System and EGV1.1 Pro Monitoring Blood Glucose System (Apr 28, 2014)
- K133389: EM40 Self-Monitoring Blood Glucose System (Apr 15, 2014)
- K133647: EMV3.1 Pro Blood Glucose System and EMV3.1 Self Monitoring Blood Glucose System (Feb 27, 2014)
- K121207: Easymax MU Self Monitoring Blood Glucose System, Easymax MU Pro Self Monitoring Blood Glucose System (May 18, 2012)

Source page: https://510kreport.com/company/eps-bio-technology