CCC DEL URUGUAY S.A.
⚠️ Moderate Risk
FEI: 3012769085 • Montevideo, Montevideo • URUGUAY
FEI Number
3012769085
Location
Montevideo, Montevideo
Country
URUGUAYAddress
Av.Gl.Jose Maria Paz 1369, , Montevideo, Montevideo, Uruguay
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).
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).
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
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 |
|---|---|---|---|
| 5/9/2025 | 89QPYSTIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR STROKE REHABILITATION | Division of Southeast Imports (DSEI) | |
| 5/2/2025 | 74PCWIMPLANTABLE PULSE GENERATOR, PROGRAMMER AND BATTERY CHARGER | Division of Southeast Imports (DSEI) | |
| 2/20/2025 | 74PCWIMPLANTABLE PULSE GENERATOR, PROGRAMMER AND BATTERY CHARGER | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is CCC DEL URUGUAY S.A.'s FDA import refusal history?
CCC DEL URUGUAY S.A. (FEI: 3012769085) has 3 FDA import refusal record(s) in our database, spanning from 2/20/2025 to 5/9/2025.
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. CCC DEL URUGUAY S.A.'s FEI number is 3012769085.
What types of violations has CCC DEL URUGUAY S.A. received?
CCC DEL URUGUAY S.A. has been cited for 4 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 CCC DEL URUGUAY S.A. come from?
All FDA import refusal data for CCC DEL URUGUAY 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.