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PIKDARE S.p.A.

Italy · Casnate Con Bernate

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, 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

2listed device types

Class I 0Class II 2Class III 0

plus 5 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

2registered devices

Class II 2

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

SASaudi ArabiaSFDA

28registered imported devices

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

CACanadaMDALL

1active device licences

Class II 1

4 including historic records

TWTaiwanTFDA

4valid device licences

Class I 2Class II 2

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

2active ARTG entries

IIa 2

HKHong KongMDACS

1valid listings

Class II 1

ILIsraelAMAR

4registrations

RURussiaRoszdravnadzor

1active registrations

Class 2a 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 States5 registration records, 0 510(k), 0 PMA, 1 excluded

Brazil2 confirmed, 0 excluded

Saudi Arabia28 confirmed, 0 excluded

Canada1 confirmed, 0 excluded

Manufacturer names merged into this page: PIKDARE S.p.A. · PIKDARE S.P.A. · PIKDARE SPA · Pikdare S.p.A

Registration details (sample)

Market	Identifier	Name	Class / date
BR	80288099016	INSUPEN ORIGINAL / INSUPEN ADVANCE	Class II
BR	80438669001	Agulha para Caneta de Insulina	Class II
SA	ME0000000891SFDAA00001	ThermoGel	—
SA	ME0000000895SFDAA00001	FullWash	—
CA	101734	SAFE BLOCK - SAFETY PEN NEEDLE	Class II

PIKDARE S.p.A.

Registrations by market

How these numbers were verified

Company information

FDA listed device types

Registration details (sample)

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