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EPS BIO TECHNOLOGY CORP.

福永生物科技股份有限公司

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2002Founded

NT$238MPaid-in capital

1Plants

53Certifications

6Patents

NT$100–500MRevenue band

Unified Business No.: 80064027
Industry: Other Manufacturing (2,432)
Main products: Medical devices & supplies (878)
Location: No. 8, R&D Rd. III, Hsinchu Science Park, Hsinchu County , Taiwan, R.O.C.
Hsinchu County (1,617) · Baoshan Township (72)
Listing: Listed (TPEx) (890) 4183
Organisation type: Company Limited by Shares
Founded: 2002-10-22
Paid-in capital: NT$ 238,000,000
Representative: Kuo Feng-lin
Phone: 03-6686868
Website: https://www.epsbio.com.tw/
Exporter: Yes — registered with the Trade Administration
Annual revenue band: NT$100–500M
Ownership: Family-run (inferred)
North American market: FCC equipment authorization FDA 510(k) clearance FDA medical device registration
Representative tenure: In office since 2015-01 (11 yrs); last handover 2015-01
Growth & profitability: Revenue 2026-09 YoY -31.0%, year-to-date -31.4%
Gross margin 17.4%, operating margin -9.4%, net margin -8.1% (2026-Q2 YTD)

Certifications 53

Medical device license (188)Official registry Valid until 2010-12-10 · Taiwan Food and Drug Administration (TFDA)
Medical device license (188)Official registry Valid until 2010-12-14 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2030-12-09 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2030-05-15 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2025-06-12 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2028-07-04 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2025-05-28 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2030-06-11 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2029-10-15 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2024-12-12 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2024-12-13 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2028-11-08 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2028-11-21 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2028-12-26 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2029-01-09 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2029-01-10 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2010-09-30 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2012-04-23 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2025-10-13 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2024-12-12 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2022-12-13 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2011-03-24 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2023-09-18 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2028-09-18 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2010-11-24 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2010-11-03 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2023-04-07 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2020-12-09 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2017-04-24 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2011-03-24 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2020-04-20 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2028-11-21 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2029-03-01 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2029-08-02 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class I) (1,430)Official registry Valid until 2023-01-28 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2027-11-22 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2017-06-01 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2028-05-02 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2031-01-29 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2030-09-22 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2021-09-23 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2022-06-01 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2022-06-22 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2022-06-01 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2028-05-02 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2021-09-23 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2022-06-01 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2022-06-22 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2011-08-23 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2021-09-23 · Taiwan Food and Drug Administration (TFDA)
Medical device license (Class II) (794)Official registry Valid until 2028-12-08 · Taiwan Food and Drug Administration (TFDA)
ISO 13485 (310)Self-reported
SA 8000 (17)Self-reported

Patents 6

2022 Electrochemical sensing module and method
2022 Blood glucose quality control solution package and blood glucose test kit
2021 Blood glucose monitoring system

North American market evidence 25

FCC equipment authorization 2AQBR 2018-06-29
FDA 510(k) clearance K201258 2021-09-01
EASYMAX Tag Self-Monitoring Blood Glucose System
FDA 510(k) clearance K190189 2019-11-01
MDT2 BLE Self-Monitoring Blood Glucose System
FDA 510(k) clearance K182057 2018-08-24
EasyMax BT Self-Monitoring Blood Glucose System
FDA 510(k) clearance K133537 2014-04-28
EGV1.1 SELF MONITORING BLOOD GLUCOSE SYSTEM AND EGV1.1 PRO MONITORING BLOOD GLUCOSE SYSTEM
FDA 510(k) clearance K133389 2014-04-15
EM40 SELF-MONITORING BLOOD GLUCOSE SYSTEM
FDA 510(k) clearance K133647 2014-02-27
EMV3.1 PRO BLOOD GLUCOSE SYSTEM AND EMV3.1 SELF MONITORING BLOOD GLUCOSE SYSTEM
FDA 510(k) clearance K121207 2012-05-18
EASYMAX MU SELF MONITORING BLOOD GLUCOSE SYSTEM, EASYMAX MU PRO SELF MONITORING BLOOD GLUCOSE SYSTEM
FDA 510(k) clearance K113243 2012-03-28
EM50 SELF MONITORING BLOOD GLUCOSE SYSTEM
FDA 510(k) clearance K112901 2011-12-23
EME SELF MONITORING BLOOD GLUCOSE SYSTEM, EME PRO SELF MONITORING BLOOD GLUCOSE SYSTEM
FDA 510(k) clearance K111728 2011-09-16
EMV3 SELF MONITORING BLOOD GLUCOSE SYSTEM, EMV3 PRO SELF MONITORING BLOOD GLUCOSE SYSTEM
FDA 510(k) clearance K112272 2011-09-07
EM44 SELF MONITORING BLOOD GLUCOSE SYSTEM, EM44 PRO SELF MONITORING BLOOD GLUCOSE SYSTEM
FDA 510(k) clearance K102345 2011-06-21
EASYMAX T1 SELF MONITORING BLOOD GLUCOSE SYSTEM, MODEL EPS10042
FDA 510(k) clearance K101037 2011-05-23
EG V1 (BL) SELF MONITORING GLUCOSE TEST SYSTEM MODEL: EPS10017
FDA 510(k) clearance K101457 2010-07-01
EASYPLUS MINI R9N SELF MONITORING BLOOD GLUCOSE SYSTEM MODEL EPS10031
FDA 510(k) clearance K092894 2010-02-24
EASYMAX V SELF MONITORING BLOOD GLUCOSE SYSTEM
FDA 510(k) clearance K092887 2009-10-21
EASYPLUS MINI MASTERDRIVER SELF MONITORING BLOOD GLUCOSE SYSTEM, MODEL EPS09009
FDA 510(k) clearance K091481 2009-08-18
EASYPLUS MINI R13N SELF MONITORING BLOOD GLUCOSE SYSTEM
FDA 510(k) clearance K091229 2009-07-31
GLUCOMANAGER DATA MANAGEMENT SOFTWARE
FDA 510(k) clearance K081796 2009-01-23
EASYPLUS MINI R2N SELF MONITORING GLUCOSE TEST SYSTEM
FDA 510(k) clearance K083099 2009-01-16
EASYMAX N SELF MONITORING BLOOD GLUCOSE SYSTEM, MODEL: EPS08008
FDA 510(k) clearance K082121 2008-09-17
EASYMAX SELF MONITORING GLUCOSE TEST SYSTEM, MODEL # EPS08005
FDA 510(k) clearance K070053 2007-12-03
EASYPLUS MINI SELF MONITORING GLUCOSE TEST SYSTEM, MODELS R1 AND R2
FDA 510(k) clearance K061992 2006-09-19
EASYPLUS SELF MONITORING GLUCOSE TEST SYSTEM, MODEL EPS04014
FDA medical device registration 3004130086 2008-10-20 – 2024-03-29
System, Test, Blood Glucose, Over The Counter; Single (Specified) Analyte Controls (Assayed And Unassayed); Glucose Dehydrogenase, Glucose and more (7)

Recent changes 1

2025-10-13
Certification expiryMedical device license (Class I) certificate expired on 2025-10-13

RSS feed · Recent changes at Taiwanese manufacturers →

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