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Elexxion Ag

⚠️ Moderate Risk

FEI: 3012119598 • Singen (Hohentwiel), Baden-Wurttemberg • GERMANY

FEI

FEI Number

3012119598

📍

Location

Singen (Hohentwiel), Baden-Wurttemberg

🇩🇪

Country

GERMANY
🏢

Address

Otto-Hahn-Str. 7, , Singen (Hohentwiel), Baden-Wurttemberg, Germany

Moderate Risk

FDA Import Risk Assessment

35.7
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
11/17/2021
Latest Refusal
11/17/2021
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
11.2×30%
Recency
17.0×20%
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

30811×

INVDEVICE

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a device for investigational use for which no exemption has been granted as prescribed by Section 520(g)

Refusal History

DateProductViolationsDivision
11/17/2021
76NVKLASER, DENTAL, SOFT TISSUE
3081INVDEVICE
Division of Northern Border Imports (DNBI)

Frequently Asked Questions

What is Elexxion Ag's FDA import refusal history?

Elexxion Ag (FEI: 3012119598) has 1 FDA import refusal record(s) in our database, spanning from 11/17/2021 to 11/17/2021.

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. Elexxion Ag's FEI number is 3012119598.

What types of violations has Elexxion Ag received?

Elexxion Ag 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 Elexxion Ag come from?

All FDA import refusal data for Elexxion Ag 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.