MEDICALgorithmics S.A.
⚠️ Moderate Risk
FEI: 3012498029 • Gdansk, Pomorskie • POLAND
FEI Number
3012498029
Location
Gdansk, Pomorskie
Country
POLANDAddress
Ul. Marynarki Polskiej 100, , Gdansk, Pomorskie, Poland
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
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 MEDICALgorithmics S.A.'s FDA import refusal history?
MEDICALgorithmics S.A. (FEI: 3012498029) has 2 FDA import refusal record(s) in our database, spanning from 5/1/2024 to 5/1/2024.
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. MEDICALgorithmics S.A.'s FEI number is 3012498029.
What types of violations has MEDICALgorithmics S.A. received?
MEDICALgorithmics S.A. 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 MEDICALgorithmics S.A. come from?
All FDA import refusal data for MEDICALgorithmics 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.