Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009288740

FEI Number

3009288740

Entity Name

Copan WASP

City/State/Country

Brescia Lombardy, IT

Establishment Address

Via Achille Grandi, 32, Brescia Lombardy 25125, IT

Establishment Type(s)

Manufacture Medical Device

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

PhenoMATRIX WASP Microscope Slides WASPLab Hardy SpeedStreakers InfoLab Loops Dove Medical Supply Loops HealthLink Inc. Loops and Needles Inoculation Loops Inoculation Needles BD Inoculation Loops Inoculation Spreaders Troy Biologicals Loops and Needles Disposable Transfer Pipettes Transfer Pipettes Double Spreader Sputum Dipper UniVerse® dispensing tube UniVerse® Dispensing Tube - Bottle MSwab bag for UniVerse UniVerse Liquid Dispensation in Tube WASP Drip Pads Disposable Drip Tray UniVerse Disposable Drip Tray WASP Collaborative Station WASP-FLO WASPLab

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QQY	Culture Plate Imaging System For Qualitative Assessment Of Resistant Organisms	Microbiology	Class 2	866.2190	2026-02-12
PPU	Microbial Colony Image Assessment System	Microbiology	Class 2	866.2190	2026-02-12
KEW	Slides, Microscope	Pathology	Class 1	864.3010	2015-12-09
JTQ	Bath, Incubators/Water, All	Microbiology	Class 1	866.2540	2013-03-12
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	Class 1	862.2050	1995-03-27
JQW	Station, Pipetting And Diluting, For Clinical Use	Clinical Chemistry	Class 1	862.2750	2020-10-01
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	2015-12-09
JTC	Device, Microtiter Diluting/Dispensing	Microbiology	Class 1	866.2500	2011-04-04
JQP	Calculator/Data Processing Module, For Clinical Use	Clinical Chemistry	Class 1	862.2100	2013-02-15

Official Correspondent

No official correspondent registered.

US Agent Details

FABRIZIO MAZZOCCHI Business: Copan Diagnostics, Inc. Email: fabrizio.mazzocchi@copangroup.com Phone: (951) 8376897

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
3015441043	Copan Industries, Inc.	Aguadilla, PR, US
2436875	COPAN DIAGNOSTICS, INC.	Murrieta, CA, US
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
K851403	Ventrex Laboratories, Inc.	VENTREZYME ALLERGEN DATA REDUCTION SYSTEM	1985-06-21
K761290	Nuclear Medical Laboratories, Inc.	COMPU-PET 300	1977-02-24
K770210	G.D. Searle and Co.	ANALYTIX AUTO SAMPLE PREP. STA. 1600	1977-02-14
K781173	Instrumentation Laboratory CO	COMPUTER INTERFACE IL 814	1978-09-14

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2008	Beckman Coulter Inc	1	FP1000 Cell Preparation System Software versions 1.1 & 1.2, Part Number 624922, for in vitro diagnostic use.
Z-0023-2013	Biomerieux Inc	1	PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC. Intended to perform the inoculation and streaking of Prepoured Media (PPM) with liquid microbiological samples.
Z-0002-2013	Beckman Coulter Inc.	1	COULTER PrepPlus, Part Number: 286600 Product Usage: The COULTER PrepPlus, is a microprocessor-controlled pipetting and diluting system, designed for automating sample preparation or assay methods. It is capable of aspirating and dispensing liquid samples.
Z-0028-2012	Beckman Coulter Inc.	1	Coulter PrepPlus 2, Part Number: 378600, Serial Numbers: 1001008698, 1001008699, and 10018700. Coulter PrePlus 2 is a microprocessor-controlled pipetting and diluting system, designed for automating sample preparation or assay methods. It is capable of aspirating and dispensing liquid samples.
Z-0007-04	Misys Healthcare Systems	1	Calculator/Data Processing Module for Clinical Use

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009288740. Last updated year: 2026. Please use registration number 3009288740 when referencing this establishment in official correspondence.