BioSphere Medical S.A.
⚠️ Moderate Risk
FEI: 3002808761 • Roissy En France, Val d'Oise • FRANCE
FEI Number
3002808761
Location
Roissy En France, Val d'Oise
Country
FRANCEAddress
Batiment A-Parc Des Nations-Paris Nord 2, 383 Rue De La Belle Etoile, Roissy En France, Val d'Oise, 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
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).
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).
Refusal History
Frequently Asked Questions
What is BioSphere Medical S.A.'s FDA import refusal history?
BioSphere Medical S.A. (FEI: 3002808761) has 2 FDA import refusal record(s) in our database, spanning from 7/29/2019 to 3/25/2025.
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. BioSphere Medical S.A.'s FEI number is 3002808761.
What types of violations has BioSphere Medical S.A. received?
BioSphere Medical S.A. 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 BioSphere Medical S.A. come from?
All FDA import refusal data for BioSphere Medical S.A. 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.