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Fysiomed Nv Sa

⚠️ Moderate Risk

FEI: 3004212641 • Edegem, Antwerp • BELGIUM

FEI

FEI Number

3004212641

📍

Location

Edegem, Antwerp

🇧🇪

Country

BELGIUM
🏢

Address

Doornstraat 87-89, , Edegem, Antwerp, Belgium

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
1
Unique Violations
12/15/2003
Latest Refusal
12/15/2003
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

4761×

NO REGISTR

The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).

Refusal History

DateProductViolationsDivision
12/15/2003
97U09ULTRASOUND PRODUCT FOR NON-MEDICAL USE
476NO REGISTR
Florida District Office (FLA-DO)

Frequently Asked Questions

What is Fysiomed Nv Sa's FDA import refusal history?

Fysiomed Nv Sa (FEI: 3004212641) has 1 FDA import refusal record(s) in our database, spanning from 12/15/2003 to 12/15/2003.

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. Fysiomed Nv Sa's FEI number is 3004212641.

What types of violations has Fysiomed Nv Sa received?

Fysiomed Nv 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 Fysiomed Nv Sa come from?

All FDA import refusal data for Fysiomed Nv 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.