Nipro Medical Ltda
⚠️ Moderate Risk
FEI: 3002533790 • Sorocaba, Sao Paulo • BRAZIL
FEI Number
3002533790
Location
Sorocaba, Sao Paulo
Country
BRAZILAddress
Avenida Nipro, 451, , Sorocaba, Sao Paulo, Brazil
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.
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).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/11/2020 | 80FOZCATHETER, INTRAVASCULAR, SHORT TERM | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 12/17/2019 | 80FOZCATHETER, INTRAVASCULAR, SHORT TERM | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 6/25/2019 | 74DTZOXYGENATOR, CARDIOPULMONARY BYPASS | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 6/25/2019 | 80FOZCATHETER, INTRAVASCULAR, SHORT TERM | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 11/2/2018 | 80FOZCATHETER, INTRAVASCULAR, SHORT TERM | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 10/18/2018 | 74DWETUBING, PUMP, CARDIOPULMONARY BYPASS | 237NO PMA | Division of Southeast Imports (DSEI) |
| 10/12/2018 | 74DQXWIRE, GUIDE, CATHETER | Division of Southeast Imports (DSEI) | |
| 6/5/2018 | 74DTZOXYGENATOR, CARDIOPULMONARY BYPASS | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 3/16/2018 | 80FOZCATHETER, INTRAVASCULAR, SHORT TERM | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 3/9/2018 | 80FOZCATHETER, INTRAVASCULAR, SHORT TERM | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 3/9/2018 | 80FOZCATHETER, INTRAVASCULAR, SHORT TERM | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 11/15/2017 | 80FOZCATHETER, INTRAVASCULAR, SHORT TERM | Division of Southeast Imports (DSEI) | |
| 9/22/2017 | 78KQQTUBING, DIALYSATE (AND CONNECTOR) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 9/22/2017 | 74DTZOXYGENATOR, CARDIOPULMONARY BYPASS | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 8/15/2017 | 78KQQTUBING, DIALYSATE (AND CONNECTOR) | 237NO PMA | Division of Southeast Imports (DSEI) |
| 8/9/2017 | 80FOZCATHETER, INTRAVASCULAR, SHORT TERM | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 6/8/2017 | 78KQQTUBING, DIALYSATE (AND CONNECTOR) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 3/21/2017 | 78KQQTUBING, DIALYSATE (AND CONNECTOR) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/24/2017 | 80FOZCATHETER, INTRAVASCULAR, SHORT TERM | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/6/2017 | 74DTZOXYGENATOR, CARDIOPULMONARY BYPASS | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 12/23/2016 | 80FOZCATHETER, INTRAVASCULAR, SHORT TERM | Division of Southeast Imports (DSEI) | |
| 10/21/2016 | 80FOZCATHETER, INTRAVASCULAR, SHORT TERM | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 8/16/2016 | 80FOZCATHETER, INTRAVASCULAR, SHORT TERM | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 7/13/2016 | 80FOZCATHETER, INTRAVASCULAR, SHORT TERM | Division of Southeast Imports (DSEI) | |
| 7/8/2016 | 74DTZOXYGENATOR, CARDIOPULMONARY BYPASS | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 5/19/2016 | 80FOZCATHETER, INTRAVASCULAR, SHORT TERM | Division of Southeast Imports (DSEI) | |
| 4/20/2016 | 80FOZCATHETER, INTRAVASCULAR, SHORT TERM | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 4/20/2016 | 80FOZCATHETER, INTRAVASCULAR, SHORT TERM | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 3/18/2016 | 74DTZOXYGENATOR, CARDIOPULMONARY BYPASS | Division of Southeast Imports (DSEI) | |
| 12/15/2015 | 80FOZCATHETER, INTRAVASCULAR, SHORT TERM | Division of Southeast Imports (DSEI) | |
| 12/3/2015 | 74DTZOXYGENATOR, CARDIOPULMONARY BYPASS | Division of Southeast Imports (DSEI) | |
| 9/14/2015 | 74DTZOXYGENATOR, CARDIOPULMONARY BYPASS | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 6/29/2015 | 80FOZCATHETER, INTRAVASCULAR, SHORT TERM | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 6/3/2015 | 74DTZOXYGENATOR, CARDIOPULMONARY BYPASS | Division of Southeast Imports (DSEI) | |
| 5/12/2015 | 74DTZOXYGENATOR, CARDIOPULMONARY BYPASS | Division of Southeast Imports (DSEI) | |
| 3/20/2015 | 74DTZOXYGENATOR, CARDIOPULMONARY BYPASS | Division of Southeast Imports (DSEI) | |
| 3/20/2015 | 74DTZOXYGENATOR, CARDIOPULMONARY BYPASS | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 3/3/2015 | 74DTZOXYGENATOR, CARDIOPULMONARY BYPASS | Division of Southeast Imports (DSEI) | |
| 3/3/2015 | 74DTZOXYGENATOR, CARDIOPULMONARY BYPASS | Division of Southeast Imports (DSEI) | |
| 10/24/2014 | 74DTZOXYGENATOR, CARDIOPULMONARY BYPASS | Division of Southeast Imports (DSEI) | |
| 9/25/2013 | 74DTZOXYGENATOR, CARDIOPULMONARY BYPASS | Division of Southeast Imports (DSEI) | |
| 7/26/2013 | 74DTQCONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS | Division of Southeast Imports (DSEI) | |
| 3/5/2013 | 74DTRHEAT-EXCHANGER, CARDIOPULMONARY BYPASS | Florida District Office (FLA-DO) | |
| 3/5/2013 | 74DTZOXYGENATOR, CARDIOPULMONARY BYPASS | Florida District Office (FLA-DO) | |
| 3/5/2013 | 74DTZOXYGENATOR, CARDIOPULMONARY BYPASS | Florida District Office (FLA-DO) | |
| 1/31/2013 | 74DTRHEAT-EXCHANGER, CARDIOPULMONARY BYPASS | Division of Southeast Imports (DSEI) | |
| 1/31/2013 | 74DTZOXYGENATOR, CARDIOPULMONARY BYPASS | Division of Southeast Imports (DSEI) | |
| 1/31/2013 | 74DTZOXYGENATOR, CARDIOPULMONARY BYPASS | Division of Southeast Imports (DSEI) | |
| 10/17/2012 | 74DTZOXYGENATOR, CARDIOPULMONARY BYPASS | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 7/24/2012 | 74DTRHEAT-EXCHANGER, CARDIOPULMONARY BYPASS | Division of Southeast Imports (DSEI) | |
| 7/24/2012 | 74DTZOXYGENATOR, CARDIOPULMONARY BYPASS | Division of Southeast Imports (DSEI) | |
| 10/20/2011 | 74DTRHEAT-EXCHANGER, CARDIOPULMONARY BYPASS | Florida District Office (FLA-DO) | |
| 5/20/2010 | 74DTZOXYGENATOR, CARDIOPULMONARY BYPASS | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 5/20/2010 | 74DTZOXYGENATOR, CARDIOPULMONARY BYPASS | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 9/2/2009 | 74DTRHEAT-EXCHANGER, CARDIOPULMONARY BYPASS | Division of Southeast Imports (DSEI) | |
| 10/2/2008 | 74DWFCATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS | 118NOT LISTED | Florida District Office (FLA-DO) |
| 11/19/2007 | 74DTZOXYGENATOR, CARDIOPULMONARY BYPASS | 118NOT LISTED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Nipro Medical Ltda's FDA import refusal history?
Nipro Medical Ltda (FEI: 3002533790) has 57 FDA import refusal record(s) in our database, spanning from 11/19/2007 to 6/11/2020.
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. Nipro Medical Ltda's FEI number is 3002533790.
What types of violations has Nipro Medical Ltda received?
Nipro Medical Ltda has been cited for 5 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 Nipro Medical Ltda come from?
All FDA import refusal data for Nipro Medical Ltda 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.