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MEDICAL CONCEPTS EUROPE B.V.

Netherlands · Gemert

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Canada, Australia, Israel, Russia — 5 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

3listed device types

Class I 3Class II 0Class III 0

plus 3 registration records and 5 510(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

1active device licences

Class II 1

2 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

1active ARTG entries

Class III 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

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 States3 registration records, 5 510(k), 0 PMA, 108 excluded

Brazil0 confirmed, 8 excluded

Saudi Arabia0 confirmed, 1 excluded

Canada1 confirmed, 9 excluded

Manufacturer names merged into this page: MEDICAL CONCEPTS · MEDICAL CONCEPTS EUROPE B.V. · MEDICAL CONCEPTS LTD.

FDA 510(k) clearances by year

11980 · K802564

21988 · K883943

11994 · K940283

12011 · K110659

FDA listed device types

Dressing, Compression 1Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) 1Coverslips, Microscope Slide 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K110659	MEDICAL CONCEPTS INTERBODY FUSION SYSTEM	2011-09-13
US	K940283	KARL STORZ ENDOVISION UROCAM/HYSTEROCAM	1994-09-28
US	K883943	CCM-1 VIDEO CAMERA SYSTEM	1988-09-28
CA	35833	I.V.S. TUNNELER	Class II

MEDICAL CONCEPTS EUROPE B.V.

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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