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SunTech Medical, Inc.

USA · Morrisville NC · www.SunTechMed.com

✓ Record-verifiedregistrations found in 14 marketsEU SRN US-MF-000002189Unified social credit code 914403006700424293

This company holds 6 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 13 overseas markets.

Registrations by market

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

CNChinaNMPA

6China registrations

Class I 3Class II 3

as of 2026-09-04

EUEuropean UnionEUDAMED

1UDI-DI device records

Class IIa 1

USUnited StatesFDA openFDA

4listed device types

Class I 0Class II 4Class III 0

plus 9 registration records and 13 510(k)

UKUnited KingdomMHRA PARD

8registered device records

Class I 1Class IIa 7

BRBrazilANVISA

4registered devices

Class I 2Class II 2

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

8registered imported devices

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

CACanadaMDALL

6active device licences

Class II 4Class III 2

18 including historic records

TWTaiwanTFDA

3valid device licences

Class II 3

SGSingaporeHSA SMDR

3device registrations

CLASS B 3

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

Import 2

AUAustraliaTGA ARTG

17active ARTG entries

Class I 6IIa 11

HKHong KongMDACS

2valid listings

Class II 2

ILIsraelAMAR

7registrations

RURussiaRoszdravnadzor

1active registrations

Class 2a 1

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 Union6 raw hits, 5 excluded, 1 confirmed

United States9 registration records, 13 510(k), 0 PMA, 4 excluded

China6 certificates (Class III 0 / II 3 / I 3), as of 2026-09-04

United Kingdom8 confirmed, 1 excluded

Brazil4 confirmed, 0 excluded

Saudi Arabia8 confirmed, 0 excluded

Canada6 confirmed, 0 excluded

Manufacturer names merged into this page: SUNTECH MEDICAL, INC. · SUNTECH MEDICAL DEVICES (SHENZHEN) CO., LTD. · SUNTECH MEDICAL INC. · Suntech Medical, Inc. · SunTech Medical, Inc.

Regulatory identity

EU manufacturer SRN: US-MF-000002189
EU authorised representative: Emergo Europe B.V.
UK responsible person: International Associates Limited
Unified social credit code: 914403006700424293
Exhibition record: CMEF 89th (Apr 2024, Shanghai) · CMEF 93rd (Apr 2026, Shanghai)

Business registration

Registration status: Active
Incorporated: 2008-02-25
Registered capital: USD 700,000
Paid-in capital: USD 700,000
Legal form: Limited liability company (wholly owned by a HK/Macao/Taiwan corporation)
Industry classification: Pharmaceutical manufacturing
Last approval date: 2025-07-30
Recognitions: Micro and small enterpriseNational High-Tech 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.

Registration details (sample)

Market	Identifier	Name	Class / date
CN	粤械注准20232071144	动态血压测量系统	Class II
CN	粤械注准20222071374	动态血压测量系统	Class II
CN	粤械注准20162071390	运动血压监测仪	Class II
CN	粤深械备20160038号	医用放大镜	Class I
EU	10840935105725	Tango M2	Class IIa
UK	16173	Stress Monitor	Class IIa
UK	16173	Non-Invasive Blood Pressure device	Class IIa
UK	36888	Ambulatory NIBP Monitor	Class IIa
US	K160439	SunTech CT40 Spot-check Vital Signs Device	2016-07-06
US	K151520	Oscar 2	2016-02-19
US	K122401	TANGO M2 BLOOD PRESSURE MONITOR	2012-11-02
BR	80070210080	BRAÇADEIRA USO ÚNICO MD	Class I
BR	80891620038	Oscar 2	Class II
BR	10361059015	Monitor de Pressão Arterial para Teste de Esforço Tango M2	Class II
SA	ME0000011455SFDAA00001	One Piece Durable BP Cuff	—
SA	ME0000004589SFDAA00009	Disposable Blood Pressure Cuff	—
CA	77251	247 SPO2 MODULE	Class III
CA	35140	TANGO+ HANDS FREE STRESS BLOOD PRESSURE MONITOR	Class II
CA	35142	ACCUTRACKER AMBULATORY BLOOD PRESSURE MONITOR	Class II

SunTech Medical, Inc.

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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