David Vision Systems Gmbh
⚠️ Moderate Risk
FEI: 3007737889 • Koblenz, Rhineland-Palatinate • GERMANY
FEI Number
3007737889
Location
Koblenz, Rhineland-Palatinate
Country
GERMANYAddress
Rudolf-Diesel-Str. 2a, , Koblenz, Rhineland-Palatinate, 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
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/5/2013 | 95RDWGENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL | 16DIRECTIONS | Philadelphia District Office (PHI-DO) |
| 6/27/2013 | 95RDWGENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL | 16DIRECTIONS | Philadelphia District Office (PHI-DO) |
| 6/27/2013 | 95RDWGENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL | 16DIRECTIONS | Philadelphia District Office (PHI-DO) |
| 9/15/2011 | 95REULASER AIMING PRODUCT, VISIBLE, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS | 476NO REGISTR | New York District Office (NYK-DO) |
Frequently Asked Questions
What is David Vision Systems Gmbh's FDA import refusal history?
David Vision Systems Gmbh (FEI: 3007737889) has 4 FDA import refusal record(s) in our database, spanning from 9/15/2011 to 9/5/2013.
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. David Vision Systems Gmbh's FEI number is 3007737889.
What types of violations has David Vision Systems Gmbh received?
David Vision Systems 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 David Vision Systems Gmbh come from?
All FDA import refusal data for David Vision Systems 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.