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Andon Health Co., Ltd.

China · Tianjin · www.jiuan.com

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, United Kingdom, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Israel, Russia — 10 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

0UDI-DI device records

USUnited StatesFDA openFDA

17listed device types

Class I 1Class II 16Class III 0

plus 33 registration records and 92 510(k)

UKUnited KingdomMHRA PARD

8registered device records

Class IIa 5IVD Annex II List B 2IVD Devices for Self-Testing 1

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

6active device licences

Class II 6

15 including historic records

TWTaiwanTFDA

1valid device licences

Class II 1

SGSingaporeHSA SMDR

5device registrations

CLASS B 5

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

12active ARTG entries

IVD Class 1 2IVD Class 3 1IIa 9

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

6registrations

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 Union29,448 raw hits, 100 excluded, 0 confirmed. Large result set — only the first 300 verified

United States33 registration records, 92 510(k), 0 PMA, 3 excluded

United Kingdom8 confirmed, 22 excluded

Brazil2 confirmed, 0 excluded

Canada6 confirmed, 0 excluded

Manufacturer names merged into this page: ANDON HEALTH CO., LTD · ANDON HEALTH CO., LTD. · Andon Health Co., Ltd.

Regulatory identity

UK responsible person: lotus global co ltd

FDA 510(k) clearances by year

32008

242009

112010

62011

52012

32013

32014

62015

52016

82017

12018

42019

32020

42021

22022

12023

22024

12025

FDA listed device types

showing 8 of 17

Analyzer, Body Composition, Exempt 1Stimulator, Nerve, Transcutaneous, Over-The-Counter 1Kit, Test, Pregnancy, Hcg, Over The Counter 1System, Measurement, Blood-Pressure, Non-Invasive 1Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter 1Stimulator, Electrical, Transcutaneous, For Arthritis 1Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature 1Piezo-Electric Stimulator For Relief Of Mosquito Bite Itch 1

Registration details (sample)

Market	Identifier	Name	Class / date
UK	35372	TENS Device	Class IIa
UK	45617	Ambulatory Blood Pressure Monitors, Electronic Sphygmomanometers	Class IIa
UK	53307	Blood Glucose Test Strips	IVD Annex II List B
US	K251113	iHealth Compare Wireless Blood Pressure Monitor(BP-300C);iHealth Compare Pro Wireless Blood Pressure Monitor(BP-300CV);iHealth Compare S Wireless Blood Pressure Monitor(BP-300V);iHealth Wireless Blood Pressure Monitor(BPX1);iHealth Blood Pressure Monitor(KD-595);iHealth Track Pro Connected Blood Pressure Monitor(KN-550LT);Semi Automatic Blood Pressure Monitor(KD-388N);Arm Blood Pressure Monitor(KD-553);Arm Blood Pressure Monitor(KD-557BR);Arm Blood Pressure Monitor(KD-558);Arm Blood Pr	2025-08-04
US	K241394	iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test Strip	2024-12-20
US	K234041	Fully Automatic Electronic Blood Pressure Monitor (KD-5811VA); Fully Automatic Electronic Blood Pressure Monitor (KD-5811BT); Fully Automatic Electronic Blood Pressure Monitor (KD-5810VA); Fully Automatic Electronic Blood Pressure Monitor (KD-5810BT); Fully Automatic Electronic Blood Pressure Monitor (KD-5920VA); Fully Automatic Electronic Blood Pressure Monitor (KD-5920BT); Fully Automatic Electronic Blood Pressure Monitor (KD-5923TS)	2024-04-22
BR	10410619014	KD-5923	Class II
BR	10410619015	kd-7920	Class II
CA	83150	WRIST BLOOD PRESSURE MONITOR	Class II
CA	83151	AUTOMATIC BLOOD PRESSURE MONITOR	Class II
CA	86016	AC ADAPTOR FOR BLOOD PRESSURE MONITORS	Class II