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Pendracare International, B.V.

Netherlands · Leek

✓ 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

1listed device types

Class I 0Class II 1Class III 0

plus 3 registration records and 2 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

2registered devices

Class II 2

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

3active device licences

Class II 3

TWTaiwanTFDA

1valid device licences

Class II 1

SGSingaporeHSA SMDR

1device registrations

CLASS D 1

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

2active ARTG entries

Class III 2

HKHong KongMDACS

1valid listings

Class IV 1

ILIsraelAMAR

7registrations

RURussiaRoszdravnadzor

3active registrations

Class 3 3

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, 2 510(k), 0 PMA, 1 excluded

Brazil2 confirmed, 0 excluded

Canada3 confirmed, 0 excluded

Manufacturer names merged into this page: PENDRACARE INTERNATIONAL B.V.

Registration details (sample)

Market	Identifier	Name	Class / date
US	K132197	CONVEY 7F GUIDING CATHETER, CONVEY 8F GUIDING CATHETER	2013-08-12
US	K120585	CONVEY GUIDING CATHETER	2012-08-08
BR	10350530144	Cateter Guia Primum	Class II
BR	10350530145	Cateter Pointer	Class II
CA	96753	CONVEY GUIDING CATHETER	Class II
CA	99370	PRIMUM HYDROPHILIC GUIDING CATHETER	Class II
CA	99371	POINTER ANGIOGRAPHIC CATHETER	Class II

Pendracare International, 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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