Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017300722

FEI Number

3017300722

Entity Name

THI TOTAL HEALTHCARE INNOVATION GMBH

City/State/Country

Feistritz im Rosental Karnten, AT

Establishment Address

Gewerbestrasse 4, Feistritz im Rosental Karnten 9181, AT

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

THI Total Healthcare Innovation GmbH (Owner Number: 10089072)

Owner / Operator Contact Address

Gewerbestrasse 4, Feistritz im Rosental, AT-2 9181, AT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ViVi Helmet ViVi Helmet25XL ViVi Helmet25 ViVi Helmet25 HPL ViVi Helmet25XL HPL ViVi Helmet HPL

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FXY	Hood, Surgical	General, Plastic Surgery	Class 2	878.4040	2023-11-03
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2025-05-31
FXZ	Helmet, Surgical	General, Plastic Surgery	Class 1	878.4040	2025-05-22

Official Correspondent

Karl Hintermann

US Agent Details

Vincent Bates Business: Ivy Surgical Solutions, LLC Email: vincebates@ivysurgical.com Phone: (858) 8229433

Related Public Records

Same Entity

THI Total Healthcare Innovation GmbH

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3031572397	THI Medikal Sanayi Ticaret A.S	Menderes Izmir, TR

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K892118	Paramount Products, Inc.	NON-STERILE MASKS AND CAPS	1989-04-20

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-06	VIASYS Med Systems	2	Stackhouse FreedomAire Lens/Hood; a sterile disposable protective head garment for use with the FreedomAire Surgical Helmet System, providing a clear plastic bubble lens and protective head hood to connect to the surgical helmet; individually packaged hoods, 12 per case; Manufactured for Viasys MedSystems, Wheeling, IL 60090
Z-0002-06	VIASYS Med Systems	2	Stackhouse Lens/Hood, Mark III Universal; a sterile disposable protective head garment for use with the Stackhouse Mark III Helmet, providing a clear plastic bubble lens and protective head hood to connect to the surgical helmet; individually packaged hoods, 12 per case; Manufactured for Viasys MedSystems, Wheeling, IL 60090

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017300722. Last updated year: 2026. Please use registration number 3017300722 when referencing this establishment in official correspondence.