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Dynarex Corporation

USA · Orangeburg

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Saudi Arabia, 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

5listed device types

Class I 1Class II 2Class III 0unclassified 2

plus 6 registration records and 27 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

2registered imported devices

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

CACanadaMDALL

51active device licences

Class II 50Class III 1

71 including historic records

TWTaiwanTFDA

0valid device licences

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 States6 registration records, 27 510(k), 0 PMA, 1 excluded

Saudi Arabia2 confirmed, 0 excluded

Canada51 confirmed, 0 excluded

Manufacturer names merged into this page: DYNAREX CORP. · DYNAREX CORPORATION · Dynarex Corporation

FDA 510(k) clearances by year

31986

11988

21989

11990

21993

11995

11996

11998

21999

12001

22002

22005

12008

22009

22011

12015

12016

12018

FDA listed device types

Cup, Eye 1Dressing, Wound, Drug 1Valve, Non-Rebreathing 1Tubes, Gastrointestinal (And Accessories) 1Polymer Patient Examination Glove 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K172266	Dynarex Three-Way Stopcock	2018-03-14
US	K152970	Dynarex Xeroform Petrolatum Dressing	2016-10-03
US	K151575	Dynarex Eye Cups	2015-09-01
SA	ME0000016175SFDAA00004	DYNARIDE™️	—
SA	ME0000016175SFDAA00007	Electric Patient Lift	—
CA	82805	LATEX EXAMINATION GLOVES	Class II
CA	82852	LATEX SURGICAL GLOVES, STERILE	Class II
CA	84209	VINYL EXAMINATION GLOVES	Class II

Dynarex Corporation

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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