Cardionics SA
⚠️ Moderate Risk
FEI: 3003675391 • Sint-Jans-Molenbeek, Brussels-Capital Region • BELGIUM
FEI Number
3003675391
Location
Sint-Jans-Molenbeek, Brussels-Capital Region
Country
BELGIUMAddress
B-1080, Gabrielle Petitstraat 4/2, Sint-Jans-Molenbeek, Brussels-Capital Region, 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).
INVDEVICE
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a device for investigational use for which no exemption has been granted as prescribed by Section 520(g)
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/22/2018 | 74DPSELECTROCARDIOGRAPH | Division of Southeast Imports (DSEI) | |
| 5/29/2012 | 74DPSELECTROCARDIOGRAPH | 118NOT LISTED | Detroit District Office (DET-DO) |
| 5/11/2012 | 74DPSELECTROCARDIOGRAPH | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 5/11/2012 | 74DPSELECTROCARDIOGRAPH | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 5/11/2012 | 74DPSELECTROCARDIOGRAPH | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 3/7/2012 | 74DPSELECTROCARDIOGRAPH | 3081INVDEVICE | Detroit District Office (DET-DO) |
| 2/28/2012 | 74DPSELECTROCARDIOGRAPH | Detroit District Office (DET-DO) | |
| 4/22/2011 | 74DPSELECTROCARDIOGRAPH | Detroit District Office (DET-DO) | |
| 3/11/2011 | 74DPSELECTROCARDIOGRAPH | 118NOT LISTED | Detroit District Office (DET-DO) |
| 9/15/2010 | 74DPSELECTROCARDIOGRAPH | Detroit District Office (DET-DO) | |
| 8/9/2010 | 74DPSELECTROCARDIOGRAPH | Detroit District Office (DET-DO) | |
| 7/21/2010 | 74DPSELECTROCARDIOGRAPH | Detroit District Office (DET-DO) | |
| 7/9/2010 | 74DXKECHOCARDIOGRAPH | 3081INVDEVICE | New York District Office (NYK-DO) |
| 6/8/2010 | 74DPSELECTROCARDIOGRAPH | Detroit District Office (DET-DO) | |
| 6/8/2010 | 74DPSELECTROCARDIOGRAPH | Detroit District Office (DET-DO) | |
| 4/23/2010 | 74DPSELECTROCARDIOGRAPH | 118NOT LISTED | Detroit District Office (DET-DO) |
Frequently Asked Questions
What is Cardionics SA's FDA import refusal history?
Cardionics SA (FEI: 3003675391) has 16 FDA import refusal record(s) in our database, spanning from 4/23/2010 to 3/22/2018.
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. Cardionics SA's FEI number is 3003675391.
What types of violations has Cardionics SA received?
Cardionics SA has been cited for 3 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 Cardionics SA come from?
All FDA import refusal data for Cardionics SA 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.