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DMC MEDICAL LIMITED

Ireland · Shannon Town Centre

✓ 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

25listed device types

Class I 10Class II 15Class III 0

plus 46 registration records and 22 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

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

SASaudi ArabiaSFDA

10registered imported devices

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

CACanadaMDALL

7active device licences

Class II 6Class III 1

37 including historic records

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 States46 registration records, 22 510(k), 0 PMA, 3 excluded

Brazil0 confirmed, 2 excluded

Saudi Arabia10 confirmed, 0 excluded

Canada7 confirmed, 0 excluded

Manufacturer names merged into this page: Philips Medical Systems DMC GmbH · DMC MEDICAL LTD. · PHILIPS MEDICAL SYSTEMS DMC GMBH · DMC MEDICAL LIMITED · INVIVO GERMANY, A DIV. OF PHILIPS MEDICAL SYSTEMS DMC GMBH · DMC MEDIKAL

Same-named companies — This database also contains companies with near-identical names: INVIVO GERMANY, A DIV. OF PHILIPS MEDICAL SYSTEMS DMC GMBH, Philips Medical Systems GmbH, Dmc. Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

22000

12007

12011

12013

22014

12015

32017

12018

12019

22020

32021

12023

32024

FDA listed device types

showing 8 of 25

Device, Beam Limiting, X-Ray, Diagnostic 1System, Image Processing, Radiological 1Solid State X-Ray Imager (Flat Panel/Digital Imager) 1System, X-Ray, Mobile 1Table, Radiographic, Non-Tilting, Powered 1Device, Spot-Film 1Table, Radiologic 1Full Field Digital, System, X-Ray, Mammographic 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K233662	Radiography 7300 C	2024-06-13
US	K233678	Radiography 7000 M	2024-02-14
US	K233945	ProxiDiagnost N90 / Precision CRF (706110, 706400)	2024-01-11
SA	ME0000003252SFDAA00012	Adult NIBP Air Hose 3.0m	—
SA	ME0000003252SFDAA00013	Neonatal NIBP Air Hose 3.0m	—
CA	761	PHILIPS PRACTIX 400	Class II
CA	8535	PHILIPS COMPUTED RADIOGRAPHIC (PCR) SYSTEMS	Class II
CA	10372	THORAVISION	Class II

DMC MEDICAL LIMITED

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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