Rontis Hellas S.A.
⚠️ Moderate Risk
FEI: 3011142981 • Larissa, Thessaly • GREECE
FEI Number
3011142981
Location
Larissa, Thessaly
Country
GREECEAddress
Industrial Area Of Larissa, , Larissa, Thessaly, Greece
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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/24/2020 | 80FOZCATHETER, INTRAVASCULAR, SHORT TERM | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 6/12/2020 | 80FOZCATHETER, INTRAVASCULAR, SHORT TERM | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 4/17/2020 | 80FOZCATHETER, INTRAVASCULAR, SHORT TERM | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 3/31/2020 | 74DQXWIRE, GUIDE, CATHETER | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 3/31/2020 | 80FOZCATHETER, INTRAVASCULAR, SHORT TERM | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 10/25/2019 | 80FOZCATHETER, INTRAVASCULAR, SHORT TERM | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 8/2/2019 | 74NIQSTENT, CORONARY, DRUG-ELUTING | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 8/2/2019 | 74DQXWIRE, GUIDE, CATHETER | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 8/2/2019 | 80FOZCATHETER, INTRAVASCULAR, SHORT TERM | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 7/31/2019 | 74DQXWIRE, GUIDE, CATHETER | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 7/31/2019 | 80FOZCATHETER, INTRAVASCULAR, SHORT TERM | 118NOT LISTED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Rontis Hellas S.A.'s FDA import refusal history?
Rontis Hellas S.A. (FEI: 3011142981) has 11 FDA import refusal record(s) in our database, spanning from 7/31/2019 to 7/24/2020.
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. Rontis Hellas S.A.'s FEI number is 3011142981.
What types of violations has Rontis Hellas S.A. received?
Rontis Hellas 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 Rontis Hellas S.A. come from?
All FDA import refusal data for Rontis Hellas 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.