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Shenzhen Hingmed Medical Instrument Co., Ltd.

China · Shenzhen Guangdong · hingmedical.com

✓ Record-verifiedregistrations found in 5 marketsEU SRN CN-MF-000004838

This company has registrations in European Union, United States, United Kingdom, Taiwan, Australia — 5 overseas markets. The China NMPA lookup is still pending.

Registrations by market

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

CNChinaNMPA

pendingnot queried

EUEuropean UnionEUDAMED

34UDI-DI device records

Class IIa 34

USUnited StatesFDA openFDA

1listed device types

Class I 0Class II 1Class III 0

plus 3 registration records and 3 510(k)

UKUnited KingdomMHRA PARD

4registered device records

Class IIa 4

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

TWTaiwanTFDA

2valid device licences

Class II 2

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

4active ARTG entries

Class I 1IIa 3

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 Union34 raw hits, 0 excluded, 34 confirmed

United States3 registration records, 3 510(k), 0 PMA

United Kingdom4 confirmed, 0 excluded

Manufacturer names merged into this page: SHENZHEN HINGMED MEDICAL INSTRUMENT CO., LTD

Regulatory identity

EU manufacturer SRN: CN-MF-000004838
EU authorised representative: Kingsmead Service B.V.
UK responsible person: Wellkang Ltd

Registration details (sample)

Market	Identifier	Name	Class / date
EU	06975164324436	WBP-02A	Class IIa
EU	06975164325044	Q06	Class IIa
EU	06975164325051	Q06B	Class IIa
EU	06975164324542	DBP-01HP	Class IIa
UK	45617	Clinical Automatic Blood Pressure Monitor	Class IIa
UK	36888	Wearable Ambulatory Blood Pressure Monitor	Class IIa
UK	16173	Clinical Automatic Blood Pressure Monitor	Class IIa
US	K251581	Wearable Ambulatory Blood Pressure Monitor (WBP-02A)	2026-02-13
US	K251307	Clinical Automatic Blood Pressure Monitor (DBP-20,DBP-20i)	2026-01-12
US	K231984	Clinical Automatic Blood Pressure Monitor (DBP-01P,DBP-01HP)	2024-03-26

Shenzhen Hingmed Medical Instrument Co., Ltd.

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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