GE MEDICAL SYSTEMS SCS
⚠️ Moderate Risk
FEI: 3022680307 • Paris • FRANCE
FEI Number
3022680307
Location
Paris
Country
FRANCEAddress
283 Rue De La Miniere Volta Repair Philippe Vinet, , Paris, , France
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
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
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
Frequently Asked Questions
What is GE MEDICAL SYSTEMS SCS's FDA import refusal history?
GE MEDICAL SYSTEMS SCS (FEI: 3022680307) has 1 FDA import refusal record(s) in our database, spanning from 4/2/2024 to 4/2/2024.
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. GE MEDICAL SYSTEMS SCS's FEI number is 3022680307.
What types of violations has GE MEDICAL SYSTEMS SCS received?
GE MEDICAL SYSTEMS SCS 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 GE MEDICAL SYSTEMS SCS come from?
All FDA import refusal data for GE MEDICAL SYSTEMS SCS 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.