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Starvac Medic Systems

⚠️ Moderate Risk

FEI: 3005040486 • Toulouse, Haute Garonne • FRANCE

FEI

FEI Number

3005040486

📍

Location

Toulouse, Haute Garonne

🇫🇷

Country

FRANCE
🏢

Address

25 rue Andre Vasseur, , Toulouse, Haute Garonne, France

Moderate Risk

FDA Import Risk Assessment

32.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
1/14/2008
Latest Refusal
1/14/2008
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
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

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
1/14/2008
74JOWSLEEVE, LIMB, COMPRESSIBLE
508NO 510(K)
New York District Office (NYK-DO)

Frequently Asked Questions

What is Starvac Medic Systems's FDA import refusal history?

Starvac Medic Systems (FEI: 3005040486) has 1 FDA import refusal record(s) in our database, spanning from 1/14/2008 to 1/14/2008.

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. Starvac Medic Systems's FEI number is 3005040486.

What types of violations has Starvac Medic Systems received?

Starvac Medic Systems 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 Starvac Medic Systems come from?

All FDA import refusal data for Starvac Medic Systems 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.