Siemens Healthineers AG
⚠️ Moderate Risk
FEI: 3004977335 • Forchheim, Bavaria • GERMANY
FEI Number
3004977335
Location
Forchheim, Bavaria
Country
GERMANYAddress
SIEMENSSTRASSE 1 -OR- Rittigfeld 1, , Forchheim, 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 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).
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/22/2023 | 90MUEFULL FIELD DIGITAL, SYSTEM, X-RAY, MAMMOGRAPHIC | Division of Northern Border Imports (DNBI) | |
| 3/13/2008 | 90IXKSYSTEM, IMAGING, X-RAY, ELECTROSTATIC | 476NO REGISTR | Chicago District Office (CHI-DO) |
| 8/23/2004 | 90IXKSYSTEM, IMAGING, X-RAY, ELECTROSTATIC | 476NO REGISTR | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Siemens Healthineers AG's FDA import refusal history?
Siemens Healthineers AG (FEI: 3004977335) has 3 FDA import refusal record(s) in our database, spanning from 8/23/2004 to 5/22/2023.
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 Healthineers AG's FEI number is 3004977335.
What types of violations has Siemens Healthineers AG received?
Siemens Healthineers AG 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 Siemens Healthineers AG come from?
All FDA import refusal data for Siemens Healthineers AG 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.