Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003591774

FEI Number

3003591774

Entity Name

Bieffe Medital S.p.A.

City/State/Country

SONDALO (SO) Sondrio, IT

Establishment Address

VIA STELVIO 94, SONDALO (SO) Sondrio 23035, IT

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Vantive US Healthcare LLC (Owner Number: 9038727)

Owner / Operator Contact Address

510 Lake Cook Road, Deerfield, IL 60015, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K162887

PMA Number

N/A

All Registered Proprietary Names

PRISMASATE PrismaSATE dialysis solutions

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KPO	Dialysate Concentrate For Hemodialysis (Liquid Or Powder)	Gastroenterology, Urology	Class 2	876.5820	2008-05-18
KPO	Dialysate Concentrate For Hemodialysis (Liquid Or Powder)	Gastroenterology, Urology	Class 2	876.5820	2017-01-10

Official Correspondent

Jennifer Masek-Little

US Agent Details

Jennifer Masek-Little Business: Baxter Healthcare Corporation Email: jennifer.masek.little@vantive.com Phone: (815) 3548549

Related Public Records

Same Entity

Vantive US Healthcare LLC

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
9610725	Vantive Manufacturing Limited	CASTLEBAR, COUNTY MAYO Connaught, IE
9612168	Vantive Manufacturing Limited	SWINFORD Mayo, IE
8010182	GAMBRO INDUSTRIES	MEYZIEU CEDEX Rhone, FR
3030306055	Vantive US Healthcare LLC	Deerfield, IL, US
3006755813	Bieffe Medital Manufacturing Oued Ellil Tunisia	Oued Ellil Manouba, TN

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2431908	EDLAW PHARMACEUTICALS, INC.	E Farmingdale, NY, US
9616277	S.M.A.D.	L'ARBRESLE Rhone, FR
3027241826	RENAL CARE DIALYSIS SOLUTIONS, S.A. DE C.V.	El Marques Queretaro, MX
1225714	Fresenius Medical Care Renal Therapies Group, LLC	Waltham, MA, US
1528807	Nipro Renal Solutions USA, Corporation	LEWISBERRY, PA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003591774. Last updated year: 2026. Please use registration number 3003591774 when referencing this establishment in official correspondence.