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Diazyme Laboratories, Inc.

✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, United Kingdom, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Israel — 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

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

0UDI-DI device records

USUnited StatesFDA openFDA

39listed device types

Class I 11Class II 27Class III 0unclassified 1

plus 38 registration records and 52 510(k)

UKUnited KingdomMHRA PARD

35registered device records

IVD C 2IVD general 33

BRBrazilANVISA

26registered devices

Class II 26

27 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

22active device licences

Class II 21Class III 1

51 including historic records

TWTaiwanTFDA

19valid device licences

Class I 2Class II 17

SGSingaporeHSA SMDR

2device registrations

CLASS C 2

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Business type not stated 1

AUAustraliaTGA ARTG

8active ARTG entries

IVD Class 1 1IVD Class 2 6IVD Class 3 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

4registrations

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 States38 registration records, 52 510(k), 0 PMA

United Kingdom35 confirmed, 0 excluded

Brazil26 confirmed, 0 excluded

Canada22 confirmed, 0 excluded

Manufacturer names merged into this page: Diazyme Laboratories, Inc. · DIAZYME LABORATORIES INC. · DIAZYME LABORATORIES, INC. · DIAZYME LABORATORIES

Regulatory identity

UK responsible person: MDSS-UK RP LIMITED

FDA 510(k) clearances by year

12003

32004

12005

32006

32007

52008

12009

32010

32011

42012

32013

32014

52016

22017

42018

22021

22022

22025

22026

FDA listed device types

showing 8 of 39

Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl 1Apolipoproteins 1Nitroprusside, Ketones (Urinary, Non-Quant.) 1Analyzer, Chemistry (Photometric, Discrete), For Clinical Use 1Enzyme Controls (Assayed And Unassayed) 1Ldl & Vldl Precipitation, Hdl 1Lipase-Esterase, Enzymatic, Photometric, Lipase 1System, Test, Oxalate 1

Registration details (sample)

Market	Identifier	Name	Class / date
UK	44700	Creatinine Liquid Reagents Assay Calibrator	IVD general
UK	44699	Diazyme Creatinine Control	IVD general
UK	53251	Creatinine Liquid Reagents Assay	IVD general
US	K253069	Lipoprotein (a) Molarity Assay	2026-06-16
US	K252336	Diazyme Immunoglobulin A Assay; Diazyme Immunoglobulin G Assay; Diazyme Immunoglobulin M Assay	2026-04-24
US	K253358	Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Light Chain Assay	2025-12-19
BR	82444370205	FAMÍLIA DIAZYME CALPROTECTIN ASSAY	Class II
BR	82444370042	Família Diazyme Human Kappa Free Light Chain	Class II
BR	82444370043	Família Diazyme Human Lambda Free Light Chain	Class II
CA	74459	DIAZYME HBA1C ENZYMATIC ASSAY KIT (WHOLE BLOOD)	Class II
CA	74461	DIAZYME CARBON DIOXIDE ENZYMATIC ASSAY KIT	Class II
CA	74462	DIAZYME CREATININE LIQUID REAGENTS ASSAY	Class II