Wem Equipamentos Eletronicos Ltda
⚠️ Moderate Risk
FEI: 3004500204 • Riberao Preto • BRAZIL
FEI Number
3004500204
Location
Riberao Preto
Country
BRAZILAddress
Rua Mal Mascarenhas De Moraes 550cep, , Riberao Preto, , 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
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/19/2004 | 79DWGELECTROSURGICAL DEVICE | Division of Southeast Imports (DSEI) | |
| 5/3/2004 | 79DWGELECTROSURGICAL DEVICE | Division of Southeast Imports (DSEI) | |
| 5/3/2004 | 79DWGELECTROSURGICAL DEVICE | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Wem Equipamentos Eletronicos Ltda's FDA import refusal history?
Wem Equipamentos Eletronicos Ltda (FEI: 3004500204) has 3 FDA import refusal record(s) in our database, spanning from 5/3/2004 to 7/19/2004.
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. Wem Equipamentos Eletronicos Ltda's FEI number is 3004500204.
What types of violations has Wem Equipamentos Eletronicos Ltda received?
Wem Equipamentos Eletronicos 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 Wem Equipamentos Eletronicos Ltda come from?
All FDA import refusal data for Wem Equipamentos Eletronicos 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.