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Well-Life Healthcare Limited

Taiwan · New Taipei City

✓ 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

12listed device types

Class I 0Class II 12Class III 0

plus 24 registration records and 29 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class 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

5 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

5active ARTG entries

Class I 1IIa 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 States24 registration records, 29 510(k), 0 PMA, 34 excluded

Brazil1 confirmed, 6 excluded

Saudi Arabia0 confirmed, 4 excluded

Canada0 confirmed, 2 excluded

Manufacturer names merged into this page: Well-Life Healthcare Limited · WELL-LIFE HEALTHCARE LIMITED

FDA 510(k) clearances by year

32002

22003

12004

12006

22007

12008

32009

22010

12011

12012

12013

22014

12016

22017

12021

32022

12024

12026

FDA listed device types

showing 8 of 12

Stimulator, Nerve, Transcutaneous, Over-The-Counter 1Pad, Heating, Powered 1Stimulator, Muscle, Powered 1Stimulator, Electrical, Non-Implantable, For Incontinence 1Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat 1Cable, Electrode 1Electrode, Cutaneous 1Interferential Current Therapy 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K251760	Well-Life Incontinence Stimulation System (WL-2405i(P))	2026-02-12
US	K233054	Well-Life Pain Relief (Menstrual Plus) Electrical Stimulator; TENS/EMS WITH Menstrual Relief Stimulator; Well-Life Pain Relief Stimulator; Menstrual Plus Stimulator	2024-10-18
US	K222528	Well-Life Probe Electrode for Stimulation/EMG Probe (Model: SA), Well-Life Incontinence Stimulation/EMG Electrode Probe, Well-Life Probe Electrode	2022-12-29
BR	80676139013	ELETRODO PERFORMA	Class II

Well-Life Healthcare Limited

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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