Home›USA›COPAN DIAGNOSTICS, INC.

COPAN DIAGNOSTICS, INC.

USA · Murrieta

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Canada — 2 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

14listed device types

Class I 11Class II 3Class III 0

plus 20 registration records and 10 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

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

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

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 States20 registration records, 10 510(k), 0 PMA, 6 excluded

Brazil0 confirmed, 3 excluded

Canada3 confirmed, 2 excluded

Manufacturer names merged into this page: COPAN DIAGNOSTICS, INC. · COPAN Diagnostics, Inc. · COPAN DIAGNOSTICS INC.

FDA 510(k) clearances by year

61995 · K946286

11999 · K993161

12001 · K001780

12004 · K042970

12006 · K061301

FDA listed device types

showing 8 of 14

Kit, Quality Control For Culture Media 1Container, Specimen Mailer And Storage, Sterile 1Dna Probe, Nucleic Acid Amplification, Chlamydia 1Device, Specimen Collection 1Culture Media, Non-Propagating Transport 1Micro Pipette 1Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use 1Culture Media, Selective Broth 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K061301	COPAN LIQUID AMIES ELUTION SWAB (ESWAB) COLLECTION AND TRANSPORT SYSTEM	2006-06-23
US	K042970	COPAN UNIVERSAL TRANSPORT MEDIUM (UTM-RT) SYSTEM	2004-12-07
US	K001780	COPAN VIRAL TRANSYSTEM	2001-07-31
CA	91481	DRY SWABS	Class II
CA	91569	CLASSIQSWABS-POLYESTER TIP	Class II
CA	91570	CLASSIQSWABS - COTTON TIP	Class II

COPAN DIAGNOSTICS, INC.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

Similar companies