Cypress Diagnostics
⚠️ Moderate Risk
FEI: 3003804235 • Landorp • BELGIUM
FEI Number
3003804235
Location
Landorp
Country
BELGIUMAddress
Langdorpsesteenmeg 160, , Landorp, , Belgium
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
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).
Refusal History
Frequently Asked Questions
What is Cypress Diagnostics's FDA import refusal history?
Cypress Diagnostics (FEI: 3003804235) has 2 FDA import refusal record(s) in our database, spanning from 12/15/2003 to 12/5/2007.
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. Cypress Diagnostics's FEI number is 3003804235.
What types of violations has Cypress Diagnostics received?
Cypress Diagnostics has been cited for 1 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 Cypress Diagnostics come from?
All FDA import refusal data for Cypress Diagnostics 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.