Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3031572397

FEI Number

3031572397

Entity Name

THI Medikal Sanayi Ticaret A.S

City/State/Country

Menderes Izmir, TR

Establishment Address

ITOB OSB Mahallesi 10005 Sokak No.60, Menderes Izmir 35471, TR

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

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

No proprietary names listed under this establishment.

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

Official Correspondent

Karl Hintermann

US Agent Details

Vincent Bates Email: vincent.bates@thigmbh.at 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
3017300722	THI TOTAL HEALTHCARE INNOVATION GMBH	Feistritz im Rosental Karnten, AT

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 3031572397. Last updated year: 2026. Please use registration number 3031572397 when referencing this establishment in official correspondence.