Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9611157

FEI Number

3002807139

Entity Name

GVS SPA

City/State/Country

Mirandola Modena, IT

Establishment Address

16, VIA CARRERI, Mirandola Modena 41037, IT

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

GVS SPA (Owner Number: 10094933)

Owner / Operator Contact Address

VIA ROMA 50, Zola Predosa, IT-BO 40069, 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
KPE	Container, I.V.	General Hospital	Class 2	880.5025	2026-01-07
KPE	Container, I.V.	General Hospital	Class 2	880.5025	2026-03-24
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2026-03-24
KPE	Container, I.V.	General Hospital	Class 2	880.5025	2026-01-07

Official Correspondent

Paola Franciosi

US Agent Details

Lorenzo Da Madice Business: ISOPLAN USA Email: isoplan@fda-510k.com Phone: (386) 8680618

Related Public Records

Same Entity

GVS 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
9614854	GVS SPA	Borgocarbonara Mantova, IT

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K041415	B.Braun Medical, Inc.	EVA TPN CONTAINER	2004-08-04
K243985	Icu Medical, Inc.	Rio Drug Reconstitution Transfer Device	2025-01-22
K222718	Hangzhou Qiantang Longyue Biotechnology Co., Ltd.	Vial Adapter	2023-03-10

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2020	The Metrix Company	2	SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 1500mL, (legless) REF 66615 - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of this product is for storage and delivery of intravenous parenteral admixtures.
Z-0002-2020	The Metrix Company	2	SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 3000mL, (legless) REF 66630 - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of this product is for storage and delivery of intravenous parenteral admixtures.
Z-0003-2020	The Metrix Company	2	SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 4000mL, (legless) REF 66640 - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of this product is for storage and delivery of intravenous parenteral admixtures.
Z-0004-2020	The Metrix Company	2	SECURE EVA - DUAL CHAMBER CONTAINER with Manifold, 1500mL, REF 66616 (Canadian distribution) - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of this product is for storage and delivery of intravenous parenteral admixtures.
Z-0005-2020	The Metrix Company	2	SECURE EVA - DUAL CHAMBER CONTAINER with Manifold, 3000mL, REF 66631 (Canadian distribution) - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of this product is for storage and delivery of intravenous parenteral admixtures.

Similar Registrations

Registration Number	Establishment Name	Location
3004181163	CGR Minnesota LLC	Inver Grove Heights, MN, US
3030989877	INTERNATIONAL FILTER PRODUCTS DBA IFP MEDICAL	Sun Valley, CA, US
1423507	CAREFUSION 2200, INC.	Vernon Hills, IL, US
3000268902	IMPERIAL TRADING LIMITED	Bridgetown Saint Michael, BB
2025816	ICU MEDICAL, INC.	SAN CLEMENTE, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9611157. Last updated year: 2026. Please use registration number 9611157 when referencing this establishment in official correspondence.