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Suzhou Minhua Medical Equipment Co.Ltd

China · Suzhou Jiangsu · www.mhmedical.com.cn

✓ Record-verifiedregistrations found in 6 marketsEU SRN CN-MF-000015569

This company has registrations in European Union, United States, Brazil, South Korea, Australia, Russia — 6 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

195UDI-DI device records

Class I 195

USUnited StatesFDA openFDA

9listed device types

Class I 6Class II 3Class III 0

plus 17 registration records and 5 510(k)

UKUnited KingdomMHRA PARD

0registered device records

BRBrazilANVISA

2registered devices

Class I 1Class II 1

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

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Business type not stated 1

AUAustraliaTGA ARTG

1active ARTG entries

Class I 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

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 Union196 raw hits, 1 excluded, 195 confirmed

United States17 registration records, 5 510(k), 0 PMA, 1 excluded

Brazil2 confirmed, 0 excluded

Manufacturer names merged into this page: Suzhou Minhua Medical Equipment Co.,Ltd. · SUZHOU MINHUA MEDICAL EQUIPMENT CO., LTD

Regulatory identity

EU manufacturer SRN: CN-MF-000015569
EU authorised representative: MedNet EC-REP GmbH

FDA 510(k) clearances by year

12015 · K143728

12017 · K171889

12018 · K180389

12023 · K233276

12025 · K241096

FDA listed device types

showing 8 of 9

Pack, Hot Or Cold, Water Circulating 1Sleeve, Limb, Compressible 1Blood Pressure Cuff 1Strap, Head, Gas Mask 1Protector, Skin Pressure 1Support, Patient Position 1Mattress, Flotation Therapy, Non-Powered 1Cushion, Wheelchair 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	16971996172839	—	Class I
EU	16971996172327	—	Class I
EU	06971996174263	—	Class I
EU	06971996174256	—	Class I
US	K241096	Venera 608 Deep Vein Thrombosis (DVT) Prevention System	2025-01-15
US	K233276	Reusable Blood Pressure Cuff	2023-12-21
US	K180389	Venera 508 Deep Vein Thrombosis (DVT) Prevention System	2018-06-29
BR	80050820010	Perneiras MAX VeinoFlow Brazil	Class I
BR	80931499001	VENERA TM 608 SERIES	Class II

Suzhou Minhua Medical Equipment 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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