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Suntech Medical

✓ Record-verifiedregistrations found in 8 marketsEU SRN US-MF-000002189

This company has registrations in European Union, United States, United Kingdom, Brazil, Saudi Arabia, Canada, Singapore, Israel — 8 overseas markets. The China NMPA lookup is still pending.

Registrations by market

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

CNChinaNMPA

n/aThis registry lists domestic registrants only

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

pendingnot queried

SGSingaporeHSA SMDR

1device registrations

CLASS B 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

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 Union6 raw hits, 5 excluded, 1 confirmed

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

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
Exhibition record: CMEF 87th (Spring 2023, Shanghai)

Registration details (sample)

Market	Identifier	Name	Class / date
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

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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