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Eden Spine Europe, SA

⚠️ Moderate Risk

FEI: 3008844415 • Geneva, Geneva • SWITZERLAND

FEI

FEI Number

3008844415

📍

Location

Geneva, Geneva

🇨🇭
🏢

Address

rue du 31 Decembre 41, , Geneva, Geneva, Switzerland

Moderate Risk

FDA Import Risk Assessment

31.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
8/23/2011
Latest Refusal
8/23/2011
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
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

1182×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

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
8/23/2011
87KWQAPPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
118NOT LISTED
508NO 510(K)
New Orleans District Office (NOL-DO)
8/23/2011
87MAXORTHOSIS, SPINAL INTERVERTEBRAL FUSION
118NOT LISTED
508NO 510(K)
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Eden Spine Europe, SA's FDA import refusal history?

Eden Spine Europe, SA (FEI: 3008844415) has 2 FDA import refusal record(s) in our database, spanning from 8/23/2011 to 8/23/2011.

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. Eden Spine Europe, SA's FEI number is 3008844415.

What types of violations has Eden Spine Europe, SA received?

Eden Spine Europe, SA 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 Eden Spine Europe, SA come from?

All FDA import refusal data for Eden Spine Europe, 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.