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Atlas Link, Inc.

USA · Manassas VA · www.atlaslink-inc.com

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, United Kingdom — 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

0UDI-DI device records

USUnited StatesFDA openFDA

1510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

3registered device records

IVD Devices for Self-Testing 3

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

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.

European Union12,630 raw hits, 100 excluded, 0 confirmed. Large result set — only the first 300 verified

United States0 registration records, 1 510(k), 0 PMA, 16 excluded

United Kingdom3 confirmed, 21 excluded

Brazil0 confirmed, 2 excluded

Canada0 confirmed, 2 excluded

Regulatory identity

UK responsible person: MT Promedt Consulting Ltd

Registration details (sample)

Market	Identifier	Name	Class / date
UK	65665	NOVA Test®Fecal Occult Blood Test	IVD Devices for Self-Testing
UK	54216	NOVA Test® One Step hCG Urine Test	IVD Devices for Self-Testing
UK	65947	NOVA Test®One Step LH Urine Test	IVD Devices for Self-Testing
US	K203246	Atlas One Step hCG Urine Pregnancy Test (Strip), Atlas One Step hCG Urine Pregnancy Test (Cassette), Atlas One Step hCG Urine Pregnancy Test (Midstream)	2021-08-04

Atlas Link, Inc.

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA 510(k) clearances by year

Registration details (sample)

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