Unomedical s.r.o.
⚠️ Moderate Risk
FEI: 3005778470 • Michalovce, Kosice • SLOVAKIA
FEI Number
3005778470
Location
Michalovce, Kosice
Country
SLOVAKIAAddress
Priemyselny Park 3, , Michalovce, Kosice, Slovakia
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/25/2017 | 78KODCATHETER, UROLOGICAL | 118NOT LISTED | Division of Northern Border Imports (DNBI) |
| 9/25/2017 | 78KODCATHETER, UROLOGICAL | 118NOT LISTED | Division of Northern Border Imports (DNBI) |
| 9/25/2017 | 78KODCATHETER, UROLOGICAL | 118NOT LISTED | Division of Northern Border Imports (DNBI) |
| 9/25/2017 | 78KODCATHETER, UROLOGICAL | 118NOT LISTED | Division of Northern Border Imports (DNBI) |
| 9/25/2017 | 78KODCATHETER, UROLOGICAL | 118NOT LISTED | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is Unomedical s.r.o.'s FDA import refusal history?
Unomedical s.r.o. (FEI: 3005778470) has 5 FDA import refusal record(s) in our database, spanning from 9/25/2017 to 9/25/2017.
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. Unomedical s.r.o.'s FEI number is 3005778470.
What types of violations has Unomedical s.r.o. received?
Unomedical s.r.o. 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 Unomedical s.r.o. come from?
All FDA import refusal data for Unomedical s.r.o. 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.