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D-R Medical Systems, Inc.

USA · Northvale

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Canada, Singapore, Russia — 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

2listed device types

Class I 1Class II 1Class III 0

plus 2 registration records and 24 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

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

5active device licences

Class II 5

14 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

1device registrations

CLASS C 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

1active registrations

Class 3 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 States2 registration records, 24 510(k), 0 PMA, 771 excluded

Brazil0 confirmed, 179 excluded

Saudi Arabia0 confirmed, 47 excluded

Canada5 confirmed, 245 excluded

Manufacturer names merged into this page: B Medical Systems SARL · MEDICAL SYSTEMS

Registration details (sample)

Market	Identifier	Name	Class / date
US	K993740	MAMEX	1999-11-26
US	K983273	XCT 2000 L PQCT BONE DENSITOMETER	1998-10-29
US	K962684	S-357 VIDEO IMAGING SYSTEM	1996-10-15
CA	78577	CUSTOM ARTHROGRAM KIT	Class II
CA	78828	CUSTOM INTERVENTIONAL RADIOLOGY KIT	Class II
CA	78830	CUSTOM VEIN KIT	Class II

D-R Medical Systems, 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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