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MENTOR MEDICAL SYSTEMS, B.V.

Netherlands · Leiden

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 10 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

1510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class II 1

6 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

2active device licences

Class II 2

7 including historic records

TWTaiwanTFDA

3valid device licences

Class II 1Class III 2

SGSingaporeHSA SMDR

5device registrations

CLASS B 1CLASS D 4

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

9active ARTG entries

Class III 8IIa 1

HKHong KongMDACS

4valid listings

Class II 2Class IV 2

ILIsraelAMAR

2registrations

RURussiaRoszdravnadzor

10active registrations

Class 2a 2Class 3 8

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 States0 registration records, 1 510(k), 0 PMA, 9 excluded

Brazil1 confirmed, 1 excluded

Canada2 confirmed, 3 excluded

Manufacturer names merged into this page: MENTOR MEDICAL LTD. · MENTOR MEDICAL SYSTEMS, B.V. · MENTOR MEDICAL SYSTEMS B.V.

Registration details (sample)

Market	Identifier	Name	Class / date
US	K022212	PORTEX PERCUTANEOUS DILATATIONAL TRACHEOSTOMY KITS	2003-03-21
BR	80145901369	MEDIDOR DE IMPLANTE MAMÁRIO DE GEL	Class II
CA	23538	SILKY INTERMITTENT CATHETER	Class II
CA	62203	GEL BREAST SIZER	Class II

MENTOR MEDICAL SYSTEMS, B.V.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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