Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014787189

FEI Number

3014787189

Entity Name

NOVOGENIA GMBH

City/State/Country

Eugendorf Salzburg, AT

Establishment Address

Strass 19, Eugendorf Salzburg 5301, AT

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Novogenia GmbH (Owner Number: 10090280)

Owner / Operator Contact Address

Strass 19, Eugendorf, AT-5 5301, 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	2024-03-07

Official Correspondent

No official correspondent registered.

US Agent Details

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

Related Public Records

Same Entity

Novogenia 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 3014787189. Last updated year: 2026. Please use registration number 3014787189 when referencing this establishment in official correspondence.