Home›USA›Dymedix Diagnostics, Inc.

Dymedix Diagnostics, Inc.

USA · Shoreview

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Canada, Australia — 4 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

4listed device types

Class I 0Class II 4Class III 0

plus 7 registration records and 2 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

2registered devices

Class II 2

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

8active device licences

Class II 8

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

1active ARTG entries

Class I 1

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 States7 registration records, 2 510(k), 0 PMA, 1 excluded

Brazil2 confirmed, 0 excluded

Canada8 confirmed, 0 excluded

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

Registration details (sample)

Market	Identifier	Name	Class / date
US	K200654	Rubicon SA System	2020-07-22
US	K192564	Disposable Gold Cup EEG Electrodes	2020-01-21
BR	80181930056	SENSOR DE FLUXO DE AR TRIPLEPLAY DYMEDIX - REUTILIZÁVEL	Class II
BR	80181930057	SENSOR DE FLUXO DE AR TRIPLEPLAY DYMEDIX - DESCARTÁVEL.	Class II
CA	93290	PERFECT FIT RESPIRATORY EFFORT BELT	Class II
CA	93291	AIRFLOW/SNORE CABLES	Class II
CA	93292	DUAL SNAP LEAD WIRE	Class II

Dymedix 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