R-VENT MEDIKAL URETIM A.S.
⚠️ Moderate Risk
FEI: 3013659051 • Torbali, Izmir • TURKEY
FEI Number
3013659051
Location
Torbali, Izmir
Country
TURKEYAddress
Yazibasi Mahallesi Balkan Caddesi Iztipsan Apt.No:33/1, Balkan Cd. Yazibasi Beldesi No. 32, Torbali, Izmir, Turkey
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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
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 |
|---|---|---|---|
| 8/9/2017 | 79KGZACCESSORIES, CATHETER | Division of Southeast Imports (DSEI) | |
| 8/9/2017 | 73OFOAIRWAY SUCTION KIT | Division of Southeast Imports (DSEI) | |
| 8/9/2017 | 73OGLOXYGEN ADMINISTRATION KIT | Division of Southeast Imports (DSEI) | |
| 8/9/2017 | 73CAHFILTER, BACTERIAL, BREATHING-CIRCUIT | Division of Southeast Imports (DSEI) | |
| 8/9/2017 | 73PNCCATHETER INTRODUCER | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is R-VENT MEDIKAL URETIM A.S.'s FDA import refusal history?
R-VENT MEDIKAL URETIM A.S. (FEI: 3013659051) has 5 FDA import refusal record(s) in our database, spanning from 8/9/2017 to 8/9/2017.
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. R-VENT MEDIKAL URETIM A.S.'s FEI number is 3013659051.
What types of violations has R-VENT MEDIKAL URETIM A.S. received?
R-VENT MEDIKAL URETIM 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 R-VENT MEDIKAL URETIM A.S. come from?
All FDA import refusal data for R-VENT MEDIKAL URETIM 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.