Tutogen Medical GmbH
⚠️ Moderate Risk
FEI: 3002924436 • Neunkirchen a. Brand, Bavaria • GERMANY
FEI Number
3002924436
Location
Neunkirchen a. Brand, Bavaria
Country
GERMANYAddress
Industriestr. 6, Neunkirchen am Brand, , Neunkirchen a. Brand, Bavaria, Germany
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
NO PMA/PDP
The article appears to be a class III dev.w/o an approved applic. for premarket approval, and/or a notice of completion of product development protocol filed per section 515(b) or exempt per sect.520(g)(1).
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
Refusal History
Frequently Asked Questions
What is Tutogen Medical GmbH's FDA import refusal history?
Tutogen Medical GmbH (FEI: 3002924436) has 1 FDA import refusal record(s) in our database, spanning from 9/1/2004 to 9/1/2004.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Tutogen Medical GmbH's FEI number is 3002924436.
What types of violations has Tutogen Medical GmbH received?
Tutogen Medical GmbH has been cited for 2 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about Tutogen Medical GmbH come from?
All FDA import refusal data for Tutogen Medical GmbH is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.