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TaiDoc Technology Corporation

Taiwan · New Taipei City · www.taidoc.com

✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, United Kingdom, Brazil, Canada, South Korea, Australia, Hong Kong, Israel, Russia — 9 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

26listed device types

Class I 9Class II 17Class III 0

plus 67 registration records and 123 510(k)

UKUnited KingdomMHRA PARD

46registered device records

Class I 5Class IIa 6Class IIb 1IVD general 17IVD Annex II List B 6IVD Devices for Self-Testing 11

BRBrazilANVISA

26registered devices

Class I 1Class II 25

30 including historic records

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

9active device licences

Class II 7Class III 2

45 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

4GMP quality-system certificates

Import 2IVD import 2

AUAustraliaTGA ARTG

23active ARTG entries

Class I 3IVD Class 1 2IVD Class 3 2IIa 14IIb 2

HKHong KongMDACS

1valid listings

Class II 1

ILIsraelAMAR

11registrations

RURussiaRoszdravnadzor

7active registrations

Class 1 1Class 2b 6

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 States67 registration records, 123 510(k), 0 PMA

United Kingdom46 confirmed, 0 excluded

Brazil26 confirmed, 0 excluded

Canada9 confirmed, 0 excluded

Manufacturer names merged into this page: TAIDOC TECHNOLOGY CORPORATION · TAIDOC TECHNOLOGY CORPORATION WUGU FACTORY

Regulatory identity

UK responsible person: Medimap Ltd

FDA 510(k) clearances by year

22004

62005

52006

82007

162008

162009

222010

162011

82012

52013

22015

42016

12017

72018

22019

22022

12024

FDA listed device types

showing 8 of 26

Kit, Test, Pregnancy, Hcg, Over The Counter 1Glucose Oxidase, Glucose 1Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature 1System, Measurement, Blood-Pressure, Non-Invasive 1Oximeter 1Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) 1Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature 1Nebulizer (Direct Patient Interface) 1

Registration details (sample)

Market	Identifier	Name	Class / date
UK	45617	"FORA ACTIVE WIRELESS plus P30 Plus BT" Blood Pressure Monitoring System	Class IIa
UK	45617	"GRx Diagnostics" Blood Pressure Monitor	Class IIa
UK	53333	ß-Ketone Control Solution (L1)	IVD Devices for Self-Testing
US	K221349	XPER Technology PREMIUM Pro Blood Glucose Monitoring System	2024-11-19
US	K201037	FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring System	2022-06-16
US	K200946	Clever Forehead Thermometer / Clever Medical Forehead Thermometer (Model TD-1241)	2022-04-05
BR	80074330021	Premium	Class II
BR	80074330022	ßCetona Premium Strip	Class II
BR	80074330023	Hemoglobina Premium Strip	Class II
CA	81482	FORA BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM	Class III
CA	85476	CLEVER TD-1110 EAR & FOREHEAD THERMOMETER	Class II
CA	96033	TD-7001 MESH NEBULIZER	Class II

TaiDoc Technology Corporation

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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