Centro de Construccion de Cardioestimuladores del Uruguay SA
⚠️ High Risk
FEI: 3010326622 • Montevideo, Montevideo • URUGUAY
FEI Number
3010326622
Location
Montevideo, Montevideo
Country
URUGUAYAddress
Avenida General Jose Maria Paz 1369, General Paz 1363, Montevideo, Montevideo, Uruguay
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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 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).
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 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.
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.
NO PMA/PDP
The article appears to be a class III dev.w/o an approved applic. for premarket approval, and/or a notice of completion of product development protocol filed per section 515(b) or exempt per sect.520(g)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/8/2025 | 84SAZSTIMULATOR, NERVE TERMINUS, TOTALLY IMPLANTED FOR CHRONIC INTRACTABLE POST-AMPUTATION PAIN OF THE LO | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 10/17/2025 | 87JDODEVICE, FIXATION, PROXIMAL FEMORAL, IMPLANT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 10/6/2025 | 84SAZSTIMULATOR, NERVE TERMINUS, TOTALLY IMPLANTED FOR CHRONIC INTRACTABLE POST-AMPUTATION PAIN OF THE LO | Division of Southeast Imports (DSEI) | |
| 9/22/2023 | 84LGWSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | Division of Southeast Imports (DSEI) | |
| 5/15/2023 | 74KRFCHARGER, PACEMAKER | Division of Southeast Imports (DSEI) | |
| 3/29/2023 | 84QLKSTIMULATOR, NEUROMUSCULAR, LOWER BACK MUSCLES, TOTALLY IMPLANTED FOR PAIN RELIEF | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 8/15/2022 | 79OABSYSTEM ABLATIONS, LOW ENERGY DIRECT CURRENT AND ACCESSORIES | Division of Southeast Imports (DSEI) | |
| 10/10/2012 | 78LNQSTIMULATOR, INTESTINAL | Division of Southeast Imports (DSEI) | |
| 4/21/2003 | 74DXYPULSE-GENERATOR, PACEMAKER, IMPLANTABLE | 2380NO PMA/PDP | New Orleans District Office (NOL-DO) |
| 4/21/2003 | 74DXYPULSE-GENERATOR, PACEMAKER, IMPLANTABLE | 508NO 510(K) | New Orleans District Office (NOL-DO) |
| 11/22/2002 | 74DXYPULSE-GENERATOR, PACEMAKER, IMPLANTABLE | 237NO PMA | New Orleans District Office (NOL-DO) |
| 9/5/2002 | 80LDQDEVICE, GENERAL MEDICAL | 341REGISTERED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Centro de Construccion de Cardioestimuladores del Uruguay SA's FDA import refusal history?
Centro de Construccion de Cardioestimuladores del Uruguay SA (FEI: 3010326622) has 12 FDA import refusal record(s) in our database, spanning from 9/5/2002 to 12/8/2025.
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. Centro de Construccion de Cardioestimuladores del Uruguay SA's FEI number is 3010326622.
What types of violations has Centro de Construccion de Cardioestimuladores del Uruguay SA received?
Centro de Construccion de Cardioestimuladores del Uruguay SA has been cited for 6 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 Centro de Construccion de Cardioestimuladores del Uruguay SA come from?
All FDA import refusal data for Centro de Construccion de Cardioestimuladores del Uruguay SA 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.