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Helix Diagnostics, Inc.

USA · West Sacramento

✓ Record-verifiedregistrations found in 1 markets

This company has registrations in United States — 1 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

15510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 15 510(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

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 States0 registration records, 15 510(k), 0 PMA, 5 excluded

Canada0 confirmed, 2 excluded

Registration details (sample)

Market	Identifier	Name	Class / date
US	K001900	ENZYME IMMUNOASSAY ANTI-SSDNA ANTIBODY TEST	2000-09-11
US	K000489	ENZYME IMMUNOASSAY ANTI-CENTROMERE ANTIBODY TEST	2000-04-05
US	K980337	DIAMEDIX IMMUNOSIMPLICITY ANA (IS-ANA) SCREEN TEST SYSTEM	1998-05-12

Helix Diagnostics, Inc.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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