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Akeda

⚠️ Moderate Risk

FEI: 3003452391 • Lystrup • DENMARK

FEI

FEI Number

3003452391

📍

Location

Lystrup

🇩🇰

Country

DENMARK
🏢

Address

S\Nderskovvej 12a, , Lystrup, , Denmark

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
10/26/2020
Latest Refusal
10/26/2020
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

471×

NON STD

The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product offered for importation into the United States which fails to comply with an applicable standard prescribed pursuant to section 534 of the FFDCA.

Refusal History

DateProductViolationsDivision
10/26/2020
89PQYNONTHERMAL SHORTWAVE THERAPY DEVICE INDICATED FOR OVER THE COUNTER USE FOR THE TREATMENT OF PAIN
47NON STD
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Akeda's FDA import refusal history?

Akeda (FEI: 3003452391) has 1 FDA import refusal record(s) in our database, spanning from 10/26/2020 to 10/26/2020.

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. Akeda's FEI number is 3003452391.

What types of violations has Akeda received?

Akeda 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 Akeda come from?

All FDA import refusal data for Akeda 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.