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Shandong Huamei Technology Co., Ltd.

China · Weifang

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Canada, Australia, Israel — 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

pendingnot queried

USUnited StatesFDA openFDA

5listed device types

Class I 2Class II 3Class III 0

plus 9 registration records and 7 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

2registered devices

Class II 2

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

2 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

5active ARTG entries

Class I 1IIb 4

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.

United States9 registration records, 7 510(k), 0 PMA, 2 excluded

Brazil2 confirmed, 6 excluded

Manufacturer names merged into this page: SHANDONG HUAMEI TECHNOLOGY CO.,LTD. · SHANDONG HUAMEI TECHNOLOGY CO., LTD. · SHANDONG HUAMEI TECHNOLOGY CO. LTD.

FDA 510(k) clearances by year

12017 · K162659

22019 · K192521

22020 · K202758

12023 · K230816

12024 · K232982

FDA listed device types

Powered Light Based Non-Laser Surgical Instrument With Thermal Effect 1Powered Laser Surgical Instrument 1Stimulator, Muscle, Powered, For Muscle Conditioning 1Brush, Dermabrasion, Powered 1Massager, Therapeutic, Electric 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K232982	EMS Sculpt Machine	2024-11-25
US	K230816	Intense Pulsed Light Treatment System	2023-04-21
US	K202758	Nd: YAG Laser Therapy Systems HM-YL900	2020-11-16
BR	82826449003	SISTEMA DE FORTALECIMENTO CORPORAL EMS	Class II
BR	82826449001	ULTRASSOM FOCALIZADO DE ALTA INTENSIDADE	Class II

Shandong Huamei Technology Co., Ltd.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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