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Tegra Medical Costa Rica Sa

✅ Low Risk

FEI: 3009166798 • La Aurora, Heredia • COSTA RICA

FEI

FEI Number

3009166798

📍

Location

La Aurora, Heredia

🇨🇷

Country

COSTA RICA
🏢

Address

Global Park 602, , La Aurora, Heredia, Costa Rica

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
1/8/2020
Latest Refusal
1/8/2020
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
1/8/2020
79GEIDEVICE, ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
341REGISTERED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Tegra Medical Costa Rica Sa's FDA import refusal history?

Tegra Medical Costa Rica Sa (FEI: 3009166798) has 1 FDA import refusal record(s) in our database, spanning from 1/8/2020 to 1/8/2020.

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. Tegra Medical Costa Rica Sa's FEI number is 3009166798.

What types of violations has Tegra Medical Costa Rica Sa received?

Tegra Medical Costa Rica 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 Tegra Medical Costa Rica Sa come from?

All FDA import refusal data for Tegra Medical Costa Rica 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.