Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3033903155

FEI Number

3033903155

Entity Name

Vantive Health GmbH

City/State/Country

Glattpark (Opfikon) Zurich, CH

Establishment Address

Thurgauerstrasse 130, Glattpark (Opfikon) Zurich 8152, CH

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on 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

K082758

PMA Number

N/A

All Registered Proprietary Names

Tipstop PRISMAFLO

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2024-12-11
KOC	Accessories, Blood Circuit, Hemodialysis	Gastroenterology, Urology	Class 2	876.5820	2025-12-17

Official Correspondent

Jennifer Masek-Little

US Agent Details

Jennifer Masek-Little Business: VANTIVE US HEALTHCARE LLC 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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3006607005	MOLNLYCKE HEALTH CARE (THAILAND), LTD.	Amphur Muang Chonburi Chon Buri, TH
3015432652	E.L.F. COSMETICS INC	Oakland, CA, US
3043138901	DONGGUAN SAMVO BIOTECHNOLOGY CO., LTD	Dongguan Guangdong, CN
3015215566	THE HAIN CELESTIAL GROUP	Hoboken, NJ, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3033903155. Last updated year: 2026. Please use registration number 3033903155 when referencing this establishment in official correspondence.