ImportRefusal LogoImportRefusal

COHERENT Dilas Diodenlaser Gmbh

⚠️ Moderate Risk

FEI: 3002790438 • Mainz, Rhineland-Palatinate • GERMANY

FEI

FEI Number

3002790438

📍

Location

Mainz, Rhineland-Palatinate

🇩🇪

Country

GERMANY
🏢

Address

Galileo-Galilei-Str. 10, COHERENT MAINZ, GALILEO-GALILEI-STRABE 10, Mainz, Rhineland-Palatinate, Germany

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
9/26/2013
Latest Refusal
9/26/2013
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
9/26/2013
79GEXPOWERED LASER SURGICAL INSTRUMENTS
476NO REGISTR
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is COHERENT Dilas Diodenlaser Gmbh's FDA import refusal history?

COHERENT Dilas Diodenlaser Gmbh (FEI: 3002790438) has 1 FDA import refusal record(s) in our database, spanning from 9/26/2013 to 9/26/2013.

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. COHERENT Dilas Diodenlaser Gmbh's FEI number is 3002790438.

What types of violations has COHERENT Dilas Diodenlaser Gmbh received?

COHERENT Dilas Diodenlaser 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 COHERENT Dilas Diodenlaser Gmbh come from?

All FDA import refusal data for COHERENT Dilas Diodenlaser 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.