Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015441043

FEI Number

3015441043

Entity Name

Copan Industries, Inc.

City/State/Country

Aguadilla, PR, US

Establishment Address

Carr. 110 KM. 28.6, Aguadilla, PR 00603, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

COPAN ITALIA Spa (Owner Number: 9016900)

Owner / Operator Contact Address

Via F. Perotti 10, 18, Brescia, IT-BS 25125, IT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Copan Liquid Amies ESwab BD ESwab Copan Liquid Amies Elution Swab HealthLink Elution Swab Rayon Fiber Swab, Non-Sterile Cotton Fiber Swab, Non-Sterile Polyester Fiber Swab, Non-Sterile Foam Swab, Non-Sterile Nylon Fiber Swab, Non-Sterile NuFoam Swab CLASSIQSwab FLOQSwab HealthLink UTM Cepheid Xpert Xpress Nasopharyngeal Collection Kit Copan Universal Transport Medium UTM-RT Quest Diagnostics VCM BD BBL UVT BD Universal Viral Transport

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JTX	Transport Systems, Anaerobic	Microbiology	Class 1	866.2900	2006-07-20
JTW	System, Transport, Aerobic	Microbiology	Class 1	866.2900	2006-07-20
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2005-11-23
JSM	Culture Media, Non-Propagating Transport	Microbiology	Class 1	866.2390	2008-01-08

Official Correspondent

ELISABETTA ZANELLA

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

COPAN ITALIA Spa

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
2436875	COPAN DIAGNOSTICS, INC.	Murrieta, CA, US
3009288740	Copan WASP	Brescia Lombardy, IT
3017063217	COPAN Diagnostics, Inc.	Carlsbad, CA, US
3002444944	COPAN ITALIA	BRESCIA Lombardy, IT

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K914894	Microtest	VIRAPURE, CHLAMYPURE AND MYCOPURE	1991-12-18

Similar Registrations

Registration Number	Establishment Name	Location
3016587486	ARX SCIENCES	Amherst, NY, US
3002444944	COPAN ITALIA	BRESCIA Lombardy, IT
3010131578	Gamma Centre of Excellence	Laval Quebec, CA
1216735	PURITAN MEDICAL PRODUCTS COMPANY LLC	GUILFORD, ME, US
9681465	Gammatom S.r.l.	GUANZATE (CO) Como, IT

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015441043. Last updated year: 2026. Please use registration number 3015441043 when referencing this establishment in official correspondence.