Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008588205

FEI Number

3008588205

Entity Name

M.V. S.R.L.

City/State/Country

Gonzaga Mantova, IT

Establishment Address

Via Don G. Dossetti, 5/7, Gonzaga Mantova 46023, IT

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

M.V. S.R.L. (Owner Number: 10038424)

Owner / Operator Contact Address

Via Fratelli Cervi, 7, Gonzaga, IT-MN 46023, IT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2011-10-13
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2015-05-11

Official Correspondent

Nazzarena Grandi

US Agent Details

Christian Costantini Business: MACLIN POWER INC. Email: sales@maclinmed.com Phone: (786) 8187337

Related Public Records

Same Entity

M.V. S.R.L.

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K812404	Nu Tech Medical Systems	BUTTERFLY NEEDLE ASSEMBLY	1981-09-09
K221518	Np Medical	NP Medical nCompass Extension Set with Stabilizing Base	2022-11-03
K953474	Medikmark, Inc.	IV START KIT	1995-10-02
K972493	Nipro Medical Corp.	NIPRO DISPOSABLE SOLUTION INFUSION SET	1997-09-18
K982672	Baxter Healthcare Corp	COLLEAGUE PUMP SYRINGE ADAPTER SET	1998-09-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2022	Bard Peripheral Vascular Inc	2	REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796
Z-0010-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24
Z-0011-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24
Z-0012-2013	Baxter Healthcare Corp. Rt.	2	Baxter Interlink System Buretrol Solution Set with 150 mL Burette (Ball-Valve Drip Chamber); a sterile Rx IV fluid pathway device. Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.
Z-0012-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, FS, YELLOW, Product Code 21-7300-24

Similar Registrations

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3006850123	JAPAN IRRADIATION SERVICE CO., LTD	Naka-gun Ibaraki, JP
3029328631	PEGASUS IMPORTS	Houston, TX, US
3010621964	ATLAS MEDICAL PRODUCTS LLC	Hialeah, FL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008588205. Last updated year: 2026. Please use registration number 3008588205 when referencing this establishment in official correspondence.