LEICA GEOSYSTEMS HUNGARY KFT
⚠️ Moderate Risk
FEI: 3013503100 • Budapest XIII, Budapest • HUNGARY
FEI Number
3013503100
Location
Budapest XIII, Budapest
Country
HUNGARYAddress
Marina setany 1, , Budapest XIII, Budapest, Hungary
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 LEICA GEOSYSTEMS HUNGARY KFT's FDA import refusal history?
LEICA GEOSYSTEMS HUNGARY KFT (FEI: 3013503100) has 1 FDA import refusal record(s) in our database, spanning from 6/7/2017 to 6/7/2017.
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. LEICA GEOSYSTEMS HUNGARY KFT's FEI number is 3013503100.
What types of violations has LEICA GEOSYSTEMS HUNGARY KFT received?
LEICA GEOSYSTEMS HUNGARY KFT 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 LEICA GEOSYSTEMS HUNGARY KFT come from?
All FDA import refusal data for LEICA GEOSYSTEMS HUNGARY KFT 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.