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COPAN ITALIA S.P.A.

Italy · Brescia

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Canada, Israel — 4 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

23listed device types

Class I 16Class II 7Class III 0

plus 34 registration records and 8 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

10registered devices

Class I 10

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

0active device licences

5 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

RURussiaRoszdravnadzor

pendingnot queried

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 States34 registration records, 8 510(k), 0 PMA, 7 excluded

Brazil10 confirmed, 1 excluded

Canada0 confirmed, 2 excluded

Manufacturer names merged into this page: COPAN ITALIA · COPAN ITALIA S.P.A. · COPAN ITALIA S.P.A · COPAN ITALIA SPA

FDA 510(k) clearances by year

21997 · K972449

12015 · K142094

12018 · K180052

12020 · K201849

12022 · K220052

22024 · K232565

FDA listed device types

showing 8 of 23

System, Transport, Aerobic 1Container, Specimen Mailer And Storage, Sterile 1Container, Specimen, Sterile 1Device, Specimen Collection 1Dna Probe, Nucleic Acid Amplification, Chlamydia 1Culture Media, Anaerobic Transport 1Culture Media, Non-Propagating Transport 1Detergent 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K232565	UriSponge	2024-10-11
US	K232357	Copan Universal Transport Medium (UTM-RT) System	2024-04-25
US	K220052	Copan FecalSwab Collection, Transport and Preservation System	2022-12-16
BR	10033430846	Copan FLOQSwabs	Class I
BR	80035670011	FAMÍLIA MEIO DE CULTURA DESTINADO À SEMEADURA PRIMÁRIA OU TRANSPORTE D	Class I
BR	10287411112	Mswab	Class I

COPAN ITALIA S.P.A.

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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