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Intermed Equipamento Medico Hospitalar Ltda

✅ Low Risk

FEI: 1000309062 • Sao Paulo, Sao Paulo • BRAZIL

FEI

FEI Number

1000309062

📍

Location

Sao Paulo, Sao Paulo

🇧🇷

Country

BRAZIL
🏢

Address

Avenida Cupece 1786, , Sao Paulo, Sao Paulo, Brazil

Low Risk

FDA Import Risk Assessment

16.3
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

1
Total Refusals
1
Unique Violations
4/29/2008
Latest Refusal
4/29/2008
Earliest Refusal

Score Breakdown

Violation Severity
30.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
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

3411×

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).

Refusal History

DateProductViolationsDivision
4/29/2008
80LDQDEVICE, GENERAL MEDICAL
341REGISTERED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Intermed Equipamento Medico Hospitalar Ltda's FDA import refusal history?

Intermed Equipamento Medico Hospitalar Ltda (FEI: 1000309062) has 1 FDA import refusal record(s) in our database, spanning from 4/29/2008 to 4/29/2008.

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. Intermed Equipamento Medico Hospitalar Ltda's FEI number is 1000309062.

What types of violations has Intermed Equipamento Medico Hospitalar Ltda received?

Intermed Equipamento Medico Hospitalar Ltda 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 Intermed Equipamento Medico Hospitalar Ltda come from?

All FDA import refusal data for Intermed Equipamento Medico Hospitalar 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.