Scanditronix Wellhofer Dosimetry
⚠️ Moderate Risk
FEI: 3004443563 • Schwarzenbruck, Bavaria • GERMANY
FEI Number
3004443563
Location
Schwarzenbruck, Bavaria
Country
GERMANYAddress
Bahnhofstr. 5, , Schwarzenbruck, 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
NON STD
The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product offered for importation into the United States which fails to comply with an applicable standard prescribed pursuant to section 534 of the FFDCA.
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 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
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/10/2008 | 90IXFTEST-PATTERN, RADIOGRAPHIC | Chicago District Office (CHI-DO) | |
| 1/10/2008 | 90IZHSYSTEM, X-RAY, MAMMOGRAPHIC | Chicago District Office (CHI-DO) | |
| 1/10/2008 | 95L22LASER PRODUCT FOR NON-MEDICAL USE | Chicago District Office (CHI-DO) | |
| 1/9/2008 | 90IZHSYSTEM, X-RAY, MAMMOGRAPHIC | 508NO 510(K) | Chicago District Office (CHI-DO) |
Frequently Asked Questions
What is Scanditronix Wellhofer Dosimetry's FDA import refusal history?
Scanditronix Wellhofer Dosimetry (FEI: 3004443563) has 4 FDA import refusal record(s) in our database, spanning from 1/9/2008 to 1/10/2008.
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. Scanditronix Wellhofer Dosimetry's FEI number is 3004443563.
What types of violations has Scanditronix Wellhofer Dosimetry received?
Scanditronix Wellhofer Dosimetry has been cited for 4 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 Scanditronix Wellhofer Dosimetry come from?
All FDA import refusal data for Scanditronix Wellhofer Dosimetry 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.