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Shenzhen Kentro Medical Electronics Co., Ltd.

China · Shenzhen Guangdong

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, South Korea, Australia — 3 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

6listed device types

Class I 0Class II 6Class III 0

plus 12 registration records and 10 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

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

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

11active ARTG entries

IIa 11

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.

United States12 registration records, 10 510(k), 0 PMA

Manufacturer names merged into this page: SHENZHEN KENTRO MEDICAL ELECTRONICS CO., LTD

FDA 510(k) clearances by year

12017

12018

12019

22020

12021

12022

22023

12024

FDA listed device types

Stimulator, Nerve, Transcutaneous, Over-The-Counter 1Stimulator, Muscle, Powered 1Electrode, Cutaneous 1Stimulator, Muscle, Powered, For Muscle Conditioning 1Stimulator, Nerve, Transcutaneous, For Pain Relief 1Stimulator, Electrical, Transcutaneous, For Arthritis 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K242332	Transcutaneous Electronic Nerve Stimulator (KTR-2301, KTR-2302, KTR-2341, KTR-2342, KTR-2401, KTR-2402, KTR-2411, KTR-2412, KTR-2491, KTR-2492, KTR-2493, KTR-2494)	2024-11-05
US	K232517	Transcutaneous Electrical Nerve Stimulator For Pain Relief (Model: KTR-2302, KTR-2401, KTR-2402, KTR-2411, KTR-2412)	2023-12-08
US	K222870	Transcutaneous Electrical Nerve Stimulator, Model: KTR-4031, KTR-4032, KTR-4012, KTR-4015, KTR-4029, KTR-4027, KTR-4026, KTR-4021, KTR-4034, KTR-4036, KTR-4037, KTR-4039	2023-05-10

Shenzhen Kentro Medical Electronics 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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