Home›USA›PHOENIX DIAGNOSTICS, INC.

PHOENIX DIAGNOSTICS, INC.

USA · Natick

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Canada — 3 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 21 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

5registered devices

Class I 1Class II 4

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

1active device licences

Class II 1

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, 21 510(k), 0 PMA, 40 excluded

Brazil5 confirmed, 6 excluded

Saudi Arabia0 confirmed, 2 excluded

Canada1 confirmed, 7 excluded

Manufacturer names merged into this page: PHOENIX DIAGNOSTICS, INC. · PHOENIX DIAGNOSTICS INC. · PHOENIX DIAGNOSTICS INC

FDA 510(k) clearances by year

101990

11991

11992

11995

11996

32001

42002

FDA listed device types

showing 8 of 9

Electrode, Ion-Specific, Chloride 1Calibrator, Multi-Analyte Mixture 1Electrode, Ion Specific, Sodium 1Electrode, Ion Specific, Potassium 1Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph 1Controls For Blood-Gases, (Assayed And Unassayed) 1General Purpose Reagent 1Multi-Analyte Controls, All Kinds (Assayed) 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K023268	PHOENIX ISE STANDARD A,B AND C FOR ROCHE/AVL SYSTEMS	2002-11-15
US	K020364	PHOENIX ISE REAGENTS FOR BECKMAN CX SYSTEMS	2002-06-04
US	K020148	pHoenix ISE Reagents FOR Olympus AU Chemistry Systems	2002-02-04
BR	80298970047	SOLUÇÃO DILUENTE	Class I
BR	80298979001	ELETRODO MEDIDOR MAXLINE	Class II
BR	80298970040	PACOTE DE REAGENTES PARA ANALISADORES - MAXLINE	Class II
CA	61680	STANDARDS FOR THE COBAS ISE MODULE	Class II

PHOENIX 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)

Similar companies