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Diamond Diagnostics, Inc.

Hungary · Budapest

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Taiwan, South Korea, Russia — 5 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

243listed device types

Class I 64Class II 177Class III 0unclassified 2

plus 192 registration records and 26 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

18registered devices

Class I 3Class II 15

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

2valid device licences

Class I 2

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

IVD import 2

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

2active registrations

Class 1 1Class 2a 1

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 States192 registration records, 26 510(k), 0 PMA, 32 excluded

Brazil18 confirmed, 7 excluded

Saudi Arabia0 confirmed, 1 excluded

Canada0 confirmed, 6 excluded

Manufacturer names merged into this page: Diamond Diagnostics Inc. · DIAMOND DIAGNOSTICS Inc · DIAMOND DIAGNOSTICS, INC · DIAMOND DIAGNOSTICS INC.

FDA 510(k) clearances by year

12001

12002

32003

42004

22006

12007

12008

12009

32010

22011

42012

12013

12014

12020

FDA listed device types

showing 8 of 243

Counter, Differential Cell 1Turbidimetric, Total Protein 1Enzyme Immunoassay, Benzodiazepine 1Radioimmunoassay, Acth 1Cardiac C-Reactive Protein, Antigen, Antiserum, And Control 1Electrode, Ion Specific, Urea Nitrogen 1Fluorescence Polarization Immunoassay, Carbamazepine 1Catalytic Methods, Amylase 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K200544	SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+	2020-10-01
US	K133751	DIAMOND DIAGNOSTICS ISE SERUM STANDARDS, DIAMOND DIAGNOSTICS ISE URINE STANDARDS	2014-08-08
US	K124009	MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS, LEVEL 1, MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS LEVEL 2, MISSION C	2013-04-17
BR	80312130007	MISSION CONTROL 123	Class I
BR	80312130009	ISE Fluid Pack	Class II
BR	80312130010	Electrode Condition Solution	Class I

Diamond Diagnostics, Inc.

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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