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EMPECS Medical Device Co., Ltd.

Korea, Republic · Seongnam-si · www.empecs.com

✓ Record-verifiedregistrations found in 7 marketsEU SRN CN-MF-000036494Unified social credit code 911201166005275868

This company holds 13 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil, Canada, Israel — 6 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

13China registrations

Class I 1Class II 10

as of 2026-09-04

EUEuropean UnionEUDAMED

7UDI-DI device records

IVD A 1IVD general 1ivd-annex-ii-list-b 5

USUnited StatesFDA openFDA

8listed device types

Class I 2Class II 6Class III 0

plus 9 registration records and 4 510(k)

UKUnited KingdomMHRA PARD

6registered device records

IVD Annex II List B 3IVD Devices for Self-Testing 3

BRBrazilANVISA

6registered devices

Class I 2Class II 4

20 including historic records

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

1active device licences

Class II 1

2 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

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 Union7 raw hits, 0 excluded, 7 confirmed

United States9 registration records, 4 510(k), 0 PMA

China13 certificates (Class III 0 / II 10 / I 1), as of 2026-09-04

United Kingdom6 confirmed, 0 excluded

Brazil6 confirmed, 0 excluded

Canada1 confirmed, 0 excluded

Manufacturer names merged into this page: TIANJIN EMPECS MEDICAL DEVICE CO., LTD. · TIANJIN EMPECS MEDICAL DEVICE CO. LTD · EMPECS MEDICAL DEVICE CO., LTD

Regulatory identity

EU manufacturer SRN: CN-MF-000036494
EU authorised representative: Shanghai International Holding Corp. GmbH(Europe)
UK responsible person: Health Ignite Ltd.
Unified social credit code: 911201166005275868
Exhibition record: CMEF 87th (Spring 2023, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 93rd (Apr 2026, Shanghai)

Business registration

Registration status: Active
Incorporated: 1993-10-25
Registered capital: USD 5,852,600
Paid-in capital: USD 5,852,600
Legal form: Limited liability company
Industry classification: Special-purpose equipment manufacturing
Last approval date: 2024-02-01
Recognitions: National High-Tech EnterpriseInnovative SME

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

12012 · K111456

12014 · K133260

22017 · K162564

FDA listed device types

Single (Specified) Analyte Controls (Assayed And Unassayed) 1Calculator/Data Processing Module, For Clinical Use 1Glucose Oxidase, Glucose 1Needle, Acupuncture, Single Use 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 1

Registration details (sample)

Market	Identifier	Name	Class / date
CN	津械注准20232220016	血糖仪	Class II
CN	津械注准20232200159	一次性使用皮内针	Class II
CN	津械注准20222200133	一次性使用针灸针	Class II
CN	津械注准20212400375	血糖质控液	Class II
EU	06936268412900	—	ivd-annex-ii-list-b
EU	06936268412856	—	ivd-annex-ii-list-b
EU	06936268412382	—	ivd-annex-ii-list-b
EU	06936268412351	—	ivd-annex-ii-list-b
UK	53333	Keto Ignite Control Solution	IVD Devices for Self-Testing
UK	53334	Keto Ignite Test Strips	IVD Devices for Self-Testing
UK	41819	Gluco Ignite Control solution	IVD Annex II List B
US	K162564	Medisign GH81 Blood Glucose Monitoring System, Medisign GH82 Blood Glucose Monitoring System, Medisign GH83 Blood Glucose Monitoring System, Medisign GH81 BT Blood Glucose Monitoring System, Medisign GH82 BT Blood Glucose Monitoring System, Medisign GH83 BT Blood Glucose Monitoring System	2017-06-07
US	K152534	Medisign MM1000 BT Blood Glucose Monitoring System, Medisign MM1100 BT Blood Glucose Monitoring System, Medisign MM1200 BT Blood Glucose Monitoring System, Smart Diabetes Bluetooth Blood Glucose Monitoring System, Medisign MM 1000 BT MULTI Blood Glucose Monitoring System, Medisign MM 1100 BT MULTI Blood Glucose Monitoring System, Medisign MM 1200 BT MULTI Blood Glucose Monitoring System, Smart Diabetes Bluetooth Pro Blood Glucose Monitoring System	2017-03-21
US	K133260	MEDISIGN BLOOD GLUCSE MONITORING SYSTEM, MEDISIGN MULTI BLOOD GLUCOSE MONITORING SYSTEM	2014-06-27
BR	82533950074	Lancetador	Class I
BR	80823320001	AGULHAS PARA ACUPUNTURA ESTÉREIS DESCARTÁVEIS - TRECKS	Class II
BR	80102512668	Lancetador Medisign LD001	Class I
CA	88837	DISPOSABLE ACUPUNCTURE NEEDLE	Class II

EMPECS Medical Device Co., Ltd.

Registrations by market

How these numbers were verified

Regulatory identity

Company information

Business registration

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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