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Tracoe Medical Gmbh

⚠️ Moderate Risk

FEI: 3005005584 • Nieder-Olm, Rhineland-Palatinate • GERMANY

FEI

FEI Number

3005005584

📍

Location

Nieder-Olm, Rhineland-Palatinate

🇩🇪

Country

GERMANY
🏢

Address

Reichelsheimer Str. 1, , Nieder-Olm, Rhineland-Palatinate, Germany

Moderate Risk

FDA Import Risk Assessment

27.1
LowModerateHighCritical

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

Statistics

2
Total Refusals
1
Unique Violations
10/12/2012
Latest Refusal
9/9/2011
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
18.3×10%
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).

Refusal History

DateProductViolationsDivision
10/12/2012
73BTOTUBE, TRACHEOSTOMY (W/WO CONNECTOR)
118NOT LISTED
New Orleans District Office (NOL-DO)
9/9/2011
73BTOTUBE, TRACHEOSTOMY (W/WO CONNECTOR)
118NOT LISTED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Tracoe Medical Gmbh's FDA import refusal history?

Tracoe Medical Gmbh (FEI: 3005005584) has 2 FDA import refusal record(s) in our database, spanning from 9/9/2011 to 10/12/2012.

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. Tracoe Medical Gmbh's FEI number is 3005005584.

What types of violations has Tracoe Medical Gmbh received?

Tracoe Medical Gmbh 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 Tracoe Medical Gmbh come from?

All FDA import refusal data for Tracoe Medical Gmbh 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.