Siemens AG Medical Solutions
⚠️ Moderate Risk
FEI: 3000275399 • Rudolstadt, Thuringia • GERMANY
FEI Number
3000275399
Location
Rudolstadt, Thuringia
Country
GERMANYAddress
Rontgenstr. 2, , Rudolstadt, Thuringia, 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
FAILS STD
The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.
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).
Refusal History
Frequently Asked Questions
What is Siemens AG Medical Solutions's FDA import refusal history?
Siemens AG Medical Solutions (FEI: 3000275399) has 2 FDA import refusal record(s) in our database, spanning from 11/21/2002 to 3/12/2018.
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. Siemens AG Medical Solutions's FEI number is 3000275399.
What types of violations has Siemens AG Medical Solutions received?
Siemens AG Medical Solutions 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 Siemens AG Medical Solutions come from?
All FDA import refusal data for Siemens AG Medical Solutions 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.