Ns Industria De Aparelhos Medicos Ltda
✅ Low Risk
FEI: 3003111608 • Sao Paulo, Sao Paulo • BRAZIL
FEI Number
3003111608
Location
Sao Paulo, Sao Paulo
Country
BRAZILAddress
Rua Francisco Pedroso De Toledo 437, , Sao Paulo, Sao Paulo, Brazil
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity 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
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.
Refusal History
Frequently Asked Questions
What is Ns Industria De Aparelhos Medicos Ltda's FDA import refusal history?
Ns Industria De Aparelhos Medicos Ltda (FEI: 3003111608) has 2 FDA import refusal record(s) in our database, spanning from 4/17/2011 to 5/10/2012.
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. Ns Industria De Aparelhos Medicos Ltda's FEI number is 3003111608.
What types of violations has Ns Industria De Aparelhos Medicos Ltda received?
Ns Industria De Aparelhos Medicos Ltda 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 Ns Industria De Aparelhos Medicos Ltda come from?
All FDA import refusal data for Ns Industria De Aparelhos Medicos 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.