Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013322902

FEI Number

3013322902

Entity Name

GESCHUETZTE WERKSTAETTEN INTEGRATIVE BETRIEBE SALZBURG GMBH

City/State/Country

St. Margareten Salzburg, AT

Establishment Address

Gewerbegebiet 192, St. Margareten Salzburg 5581, AT

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Geschuetzte Werkstaetten Integrative Betriebe Salzburg GmbH (Owner Number: 10090874)

Owner / Operator Contact Address

Gewerbegebiet 192, St. Margareten, AT-5 5581, AT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Novo Saliva Kit

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NNK	Container, Specimen Mailer And Storage, Non-Sterile	Pathology	Class 1	864.3250	2024-05-27

Official Correspondent

Wolfgang Pichler

US Agent Details

Frederick W. Stein Email: regulatory@10xhealthsystem.com Phone: (630) 4277452

Related Public Records

Same Entity

Geschuetzte Werkstaetten Integrative Betriebe Salzburg GmbH

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013322902. Last updated year: 2026. Please use registration number 3013322902 when referencing this establishment in official correspondence.