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Heart Transverter Sa

✅ Low Risk

FEI: 3008644536 • Heredia, Heredia • COSTA RICA

FEI

FEI Number

3008644536

📍

Location

Heredia, Heredia

🇨🇷

Country

COSTA RICA
🏢

Address

6a A Zona Franca Metro, , Heredia, Heredia, Costa Rica

Low Risk

FDA Import Risk Assessment

24.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
9/7/2011
Latest Refusal
9/7/2011
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
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

1181×

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).

Refusal History

DateProductViolationsDivision
9/7/2011
80LDQDEVICE, GENERAL MEDICAL
118NOT LISTED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Heart Transverter Sa's FDA import refusal history?

Heart Transverter Sa (FEI: 3008644536) has 1 FDA import refusal record(s) in our database, spanning from 9/7/2011 to 9/7/2011.

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. Heart Transverter Sa's FEI number is 3008644536.

What types of violations has Heart Transverter Sa received?

Heart Transverter Sa 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 Heart Transverter Sa come from?

All FDA import refusal data for Heart Transverter Sa 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.