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Neumovent Tecme

⚠️ Moderate Risk

FEI: 3005036283 • Cordoba • ARGENTINA

FEI

FEI Number

3005036283

📍

Location

Cordoba

🇦🇷

Country

ARGENTINA
🏢

Address

Av Fuerza Aerea, , Cordoba, , Argentina

Moderate Risk

FDA Import Risk Assessment

27.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
10/2/2006
Latest Refusal
10/2/2006
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
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

3412×

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).

5082×

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
10/2/2006
73MODACCESSORY TO CONTINUOUS VENTILATOR (RESPIRATOR)
341REGISTERED
508NO 510(K)
Florida District Office (FLA-DO)
10/2/2006
73NBMVENTILATOR, AUTOMATIC CONTROLLER, PERCENT OXYGEN
341REGISTERED
508NO 510(K)
Florida District Office (FLA-DO)

Frequently Asked Questions

What is Neumovent Tecme's FDA import refusal history?

Neumovent Tecme (FEI: 3005036283) has 2 FDA import refusal record(s) in our database, spanning from 10/2/2006 to 10/2/2006.

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. Neumovent Tecme's FEI number is 3005036283.

What types of violations has Neumovent Tecme received?

Neumovent Tecme 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 Neumovent Tecme come from?

All FDA import refusal data for Neumovent Tecme 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.