ImportRefusal LogoImportRefusal

Tecnimedica Sa

⚠️ Moderate Risk

FEI: 3004744284 • Santo Domingo • DOMINICAN REPUBLIC

FEI

FEI Number

3004744284

📍

Location

Santo Domingo

🇩🇴
🏢

Address

Calle Felix Mota No 75 Ens Los Prados, , Santo Domingo, , Dominican Republic

Moderate Risk

FDA Import Risk Assessment

28.3
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

1
Total Refusals
2
Unique Violations
4/9/2018
Latest Refusal
4/9/2018
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
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).

5081×

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

DateProductViolationsDivision
4/9/2018
73BSKCUFF, TRACHEAL TUBE, INFLATABLE
118NOT LISTED
508NO 510(K)
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Tecnimedica Sa's FDA import refusal history?

Tecnimedica Sa (FEI: 3004744284) has 1 FDA import refusal record(s) in our database, spanning from 4/9/2018 to 4/9/2018.

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. Tecnimedica Sa's FEI number is 3004744284.

What types of violations has Tecnimedica Sa received?

Tecnimedica Sa 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 Tecnimedica Sa come from?

All FDA import refusal data for Tecnimedica 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.