Semaan Praxisbedarf
⚠️ Moderate Risk
FEI: 3006062850 • Bonn, North Rhine-Westphalia • GERMANY
FEI Number
3006062850
Location
Bonn, North Rhine-Westphalia
Country
GERMANYAddress
Agnesstr. 7, , Bonn, North Rhine-Westphalia, 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
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
NO REGISTR
The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).
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 Semaan Praxisbedarf's FDA import refusal history?
Semaan Praxisbedarf (FEI: 3006062850) has 1 FDA import refusal record(s) in our database, spanning from 3/16/2007 to 3/16/2007.
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. Semaan Praxisbedarf's FEI number is 3006062850.
What types of violations has Semaan Praxisbedarf received?
Semaan Praxisbedarf has been cited for 3 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 Semaan Praxisbedarf come from?
All FDA import refusal data for Semaan Praxisbedarf 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.