MEDICAL SAN INDUSTRIA DE EQUIPAMENTOS MEDICOS EIRELI
⚠️ Moderate Risk
FEI: 3029897009 • Lajeado, Lajeado Rio Grande Do Sul • BRAZIL
FEI Number
3029897009
Location
Lajeado, Lajeado Rio Grande Do Sul
Country
BRAZILAddress
Bloco 20 And 406, Rua Alberto Muller, 1100 Suite 404, Lajeado, Lajeado Rio Grande Do Sul, 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
NON STD
The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product offered for importation into the United States which fails to comply with an applicable standard prescribed pursuant to section 534 of the FFDCA.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/7/2025 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | 47NON STD | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is MEDICAL SAN INDUSTRIA DE EQUIPAMENTOS MEDICOS EIRELI's FDA import refusal history?
MEDICAL SAN INDUSTRIA DE EQUIPAMENTOS MEDICOS EIRELI (FEI: 3029897009) has 1 FDA import refusal record(s) in our database, spanning from 1/7/2025 to 1/7/2025.
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. MEDICAL SAN INDUSTRIA DE EQUIPAMENTOS MEDICOS EIRELI's FEI number is 3029897009.
What types of violations has MEDICAL SAN INDUSTRIA DE EQUIPAMENTOS MEDICOS EIRELI received?
MEDICAL SAN INDUSTRIA DE EQUIPAMENTOS MEDICOS EIRELI has been cited for 1 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 MEDICAL SAN INDUSTRIA DE EQUIPAMENTOS MEDICOS EIRELI come from?
All FDA import refusal data for MEDICAL SAN INDUSTRIA DE EQUIPAMENTOS MEDICOS EIRELI 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.