Medin A.S.
⚠️ Moderate Risk
FEI: 3002829122 • Nove Mesto Na Morave • CZECH REPUBLIC
FEI Number
3002829122
Location
Nove Mesto Na Morave
Country
CZECH REPUBLICAddress
Vlachovicka 619, , Nove Mesto Na Morave, , Czech Republic
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 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/27/2017 | 76EKWBROACH, ENDODONTIC | Division of Southeast Imports (DSEI) | |
| 12/27/2017 | 76EKKSPREADER, PULP CANAL FILLING MATERIAL, ENDODONTIC | Division of Southeast Imports (DSEI) | |
| 12/27/2017 | 76EJLBUR, DENTAL | Division of Southeast Imports (DSEI) | |
| 6/22/2009 | 80LDQDEVICE, GENERAL MEDICAL | Florida District Office (FLA-DO) | |
| 3/2/2009 | 80LDQDEVICE, GENERAL MEDICAL | 118NOT LISTED | Florida District Office (FLA-DO) |
| 8/10/2005 | 79GFABLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Medin A.S.'s FDA import refusal history?
Medin A.S. (FEI: 3002829122) has 6 FDA import refusal record(s) in our database, spanning from 8/10/2005 to 12/27/2017.
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. Medin A.S.'s FEI number is 3002829122.
What types of violations has Medin A.S. received?
Medin A.S. 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 Medin A.S. come from?
All FDA import refusal data for Medin A.S. 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.