Swissray Medical AG
✅ Low Risk
FEI: 3002143662 • Hochdorf, Luzern • SWITZERLAND
FEI Number
3002143662
Location
Hochdorf, Luzern
Country
SWITZERLANDAddress
Turbistrasse 25-27, , Hochdorf, Luzern, Switzerland
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity violations.
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
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
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 Swissray Medical AG's FDA import refusal history?
Swissray Medical AG (FEI: 3002143662) has 1 FDA import refusal record(s) in our database, spanning from 9/12/2003 to 9/12/2003.
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. Swissray Medical AG's FEI number is 3002143662.
What types of violations has Swissray Medical AG received?
Swissray Medical AG 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 Swissray Medical AG come from?
All FDA import refusal data for Swissray Medical 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.