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YD Diagnostics CORP.

Korea, Republic · Yongin-si Gyeonggi-do · www.yd-diagnostics.com

✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, United Kingdom, Brazil, Taiwan, Singapore, Australia, Israel, Russia — 8 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

0UDI-DI device records

USUnited StatesFDA openFDA

19listed device types

Class I 13Class II 6Class III 0

plus 11 registration records and 5 510(k)

UKUnited KingdomMHRA PARD

3registered device records

IVD general 3

BRBrazilANVISA

8registered devices

Class II 8

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

5valid device licences

Class I 3Class II 2

SGSingaporeHSA SMDR

1device registrations

CLASS B 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

2active ARTG entries

IVD Class 2 2

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

RURussiaRoszdravnadzor

9active registrations

Class 1 1Class 2a 8

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 Union3,028 raw hits, 300 excluded, 0 confirmed. Large result set — only the first 300 verified

United States11 registration records, 5 510(k), 0 PMA, 1 excluded

United Kingdom3 confirmed, 35 excluded

Brazil8 confirmed, 0 excluded

Manufacturer names merged into this page: YD DIAGNOSTICS · YD DIAGNOSTICS CORPORATION · YD DIAGNOSTICS CORP.

Regulatory identity

UK responsible person: Chirus Limited

FDA 510(k) clearances by year

12002 · K023027

12005 · K050801

12006 · K060953

12015 · K141874

12018 · K182038

FDA listed device types

showing 8 of 19

Visual, Pregnancy Hcg, Prescription Use 1Kit, Test, Pregnancy, Hcg, Over The Counter 1Reagent, Occult Blood 1Blood, Occult, Colorimetric, In Urine 1Method, Enzymatic, Glucose (Urinary, Non-Quantitative) 1Enzymatic Method, Creatinine 1Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) 1Fixative, Alcohol Containing 1

Registration details (sample)

Market	Identifier	Name	Class / date
UK	30219	Multiple urine analyte IVD, control	IVD general
UK	54514	Multiple urine analyte IVD, kit, colorimetric dipstick, rapid	IVD general
UK	57861	Urine analyser IVD, point-of-care	IVD general
US	K182038	URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzer	2018-12-10
US	K141874	URISCAN OPTIMA	2015-05-28
US	K060953	OCCULTECH FECAL OCCULT BLOOD RAPID TEST	2006-09-18
BR	10350840057	URISCAN 11	Class II
BR	10350840072	URISCAN PRO - ANALISADOR QUIMICO DE URINA	Class II
BR	10350840230	FAMÍLIA DE CONTROLES DE URINA URITROL LIQUID	Class II