HomeTaiwanEPS Bio Technology Corp.

EPS Bio Technology Corp.

Taiwan · Hsinchu · www.epsbio.com
✓ Record-verifiedregistrations found in 4 marketsUnified social credit code 91370613706324453C

This company holds 39 NMPA certificates in China and has registrations in United States, Canada, Singapore — 3 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
39China registrations
Class I 18Class II 17
as of 2026-09-04
EUEuropean UnionEUDAMED
0UDI-DI device records
USUnited StatesFDA openFDA
7listed device types
Class I 2Class II 5Class III 0
plus 9 registration records and 24 510(k)
UKUnited KingdomMHRA PARD
0registered device records
BRBrazilANVISA
0registered devices
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
4 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
1device registrations
CLASS C 1
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
pendingnot queried
Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

European Union3,138 raw hits, 300 excluded, 0 confirmed. Large result set — only the first 300 verified
United States9 registration records, 24 510(k), 0 PMA
China39 certificates (Class III 0 / II 17 / I 18), as of 2026-09-04
United Kingdom0 confirmed, 5 excluded
Manufacturer names merged into this page: EPS BIO TECHNOLOGY CORP.

Regulatory identity

Unified social credit code
91370613706324453C
Exhibition record
CMEF 87th (Spring 2023, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 93rd (Apr 2026, Shanghai)

Company information

Country
Taiwan
City
Hsinchu
Social-insurance enrolees
198
Annual revenue
RMB 100–500M
Website
www.epsbio.com
Product categories
Integrated Care, Rehabilitation & HomecareHomecare, long-term care & ageing

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

Business registration

Registration status
Active
Incorporated
2000-10-16
Registered capital
CNY 27,233,820
Paid-in capital
CNY 27,233,820
Legal form
Joint-stock limited company (unlisted)
Industry classification
Special-purpose equipment manufacturing
Last approval date
2026-08-11
Recognitions
Micro and small enterpriseNational High-Tech EnterpriseSRDI SMEGazelle enterpriseAbove-designated-size industrial enterprise

Business registration data from Tianyancha, as of 2026-09-02. Public registry information only; legal representative and contact-person details are not collected. The figure is the number of employees enrolled in social insurance as declared by the company, which may differ from actual headcount.

FDA 510(k) clearances by year

12005
12006
12007
12008
52009
22010
52011
22012
32014
12018
12019
12021

FDA listed device types

Glucose Oxidase, Glucose 1Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature 1Multiple Use Blood Lancet For Single Patient Use Only 1System, Test, Blood Glucose, Over The Counter 1Glucose Dehydrogenase, Glucose 1Single (Specified) Analyte Controls (Assayed And Unassayed) 1Multi-Analyte Controls, All Kinds (Assayed) 1

Registration details (sample)

MarketIdentifierNameClass / date
CN鲁械注准20262400328血气电解质分析仪用质控品Class II
CN鲁械注准20242400829血清淀粉样蛋白A质控品Class II
CN鲁械注准20242400828C反应蛋白质控品Class II
CN鲁械注准20242220088全自动三分群血细胞分析仪Class II
USK201258EASYMAX Tag Self-Monitoring Blood Glucose System2021-09-01
USK190189MDT2 BLE Self-Monitoring Blood Glucose System2019-11-01
USK182057EasyMax BT Self-Monitoring Blood Glucose System2018-08-24

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