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Privapath Diagnostics Ltd

Ireland · Dublin

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Canada — 2 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

pendingnot queried

USUnited StatesFDA openFDA

9listed device types

Class I 4Class II 5Class III 0

plus 10 registration records and 2 510(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

3 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

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 States10 registration records, 2 510(k), 0 PMA

Manufacturer names merged into this page: Privapath Diagnostics Ltd · PRIVAPATH DIAGNOSTICS LTD. ALSO TRADING AS LETSGETCHECKED

FDA 510(k) clearances by year

12023 · DEN200070

12025 · K242680

FDA listed device types

showing 8 of 9

Test, Vaginal, Bacterial Sialidase 1Container, Specimen Mailer And Storage, Non-Sterile 1Urine Collection Kit (Excludes Hiv Testing) 1Applicator, Absorbent Tipped, Sterile 1System For Detection Of Nucleic Acid From Non-Viral Microorganism(S) Causing Stis Using Specimens Collected At Home 1Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature 1Device For Home Collection And Transport Of Vaginal Specimens By Lay Users For Use In An Approved Hpv Molecular Assay 1Dna Specimen Collection, Saliva 1

Market	Identifier	Name	Class / date
US	K242680	LetsGetChecked Impress	2025-01-13
US	DEN200070	Simple 2 Test	2023-11-15

Privapath Diagnostics 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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