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ARTSANA S.P.A

Italy · Grandate

✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Australia, Israel, Russia — 7 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

3510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 3 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

4registered devices

Class I 3Class II 1

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

SASaudi ArabiaSFDA

2registered imported devices

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

CACanadaMDALL

1active device licences

Class II 1

3 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

5active ARTG entries

Class I 4IIa 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

RURussiaRoszdravnadzor

2active registrations

Class 1 2

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, 3 510(k), 0 PMA

Brazil4 confirmed, 1 excluded

Saudi Arabia2 confirmed, 1 excluded

Canada1 confirmed, 0 excluded

Manufacturer names merged into this page: ARTSANA S.P.A. · ARTSANA S.P.A · Artsana S.p.A

Registration details (sample)

Market	Identifier	Name	Class / date
US	K151311	Safe Block Pen Needle	2016-02-10
US	K052667	ARTSANA PISTON AND INSULIN SYRINGES	2005-11-25
US	K051783	ARTSANA PEN NEEDLES, ARTSANA INJECTION NEEDLES	2005-10-04
BR	80197659001	TERMÔMETRO DIGITAL PEDIÁTRICO ULTRA SMALL COLORS	Class II
BR	80197650003	Aspirador nasal PhysioClean - Tradicional	Class I
BR	80197650004	Bico para Aspirador nasal PhysioClean	Class I
SA	ME0000020599SFDAA00001	Chicco PhysioClean	—
SA	ME0000020602SFDAA00001	Chicco PhysioClean	—
CA	92158	SAFE BLOCK - SAFETY PEN NEEDLE	Class II

ARTSANA S.P.A

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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