Medi Gmbh Co Kg Medicusstr 1
⚠️ Moderate Risk
FEI: 3011393519 • Germany • GERMANY
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/3/2015 | 80DWLSTOCKING, MEDICAL SUPPORT | 341REGISTERED | Florida District Office (FLA-DO) |
| 4/3/2015 | 80DWLSTOCKING, MEDICAL SUPPORT | 341REGISTERED | Florida District Office (FLA-DO) |
| 4/3/2015 | 80DWLSTOCKING, MEDICAL SUPPORT | 341REGISTERED | Florida District Office (FLA-DO) |
| 4/3/2015 | 80DWLSTOCKING, MEDICAL SUPPORT | 341REGISTERED | Florida District Office (FLA-DO) |
| 4/3/2015 | 80DWLSTOCKING, MEDICAL SUPPORT | 341REGISTERED | Florida District Office (FLA-DO) |
| 4/3/2015 | 80DWLSTOCKING, MEDICAL SUPPORT | 341REGISTERED | Florida District Office (FLA-DO) |
| 4/3/2015 | 80DWLSTOCKING, MEDICAL SUPPORT | 341REGISTERED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Medi Gmbh Co Kg Medicusstr 1's FDA import refusal history?
Medi Gmbh Co Kg Medicusstr 1 (FEI: 3011393519) has 7 FDA import refusal record(s) in our database, spanning from 4/3/2015 to 4/3/2015.
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. Medi Gmbh Co Kg Medicusstr 1's FEI number is 3011393519.
What types of violations has Medi Gmbh Co Kg Medicusstr 1 received?
Medi Gmbh Co Kg Medicusstr 1 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 Medi Gmbh Co Kg Medicusstr 1 come from?
All FDA import refusal data for Medi Gmbh Co Kg Medicusstr 1 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.