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BERGFELD LASERTECH GMBH

⚠️ Moderate Risk

FEI: 3026344444 • Aachen, North Rhine-Westphalia • GERMANY

FEI

FEI Number

3026344444

📍

Location

Aachen, North Rhine-Westphalia

🇩🇪

Country

GERMANY
🏢

Address

Roermonder Str. 110a, , Aachen, North Rhine-Westphalia, Germany

Moderate Risk

FDA Import Risk Assessment

40.0
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
6/13/2025
Latest Refusal
6/13/2025
Earliest Refusal

Score Breakdown

Violation Severity
45.0×40%
Refusal Volume
11.2×30%
Recency
88.4×20%
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

2781×

NO TAG

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 to which is not affixed a certification in the form of a label or tag in conformity with section 534(h).

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
6/13/2025
95RFELASER CUTTER, MATERIAL PROCESSING LASER PRODUCTS
278NO TAG
476NO REGISTR
Division of West Coast Imports (DWCI)

Frequently Asked Questions

What is BERGFELD LASERTECH GMBH's FDA import refusal history?

BERGFELD LASERTECH GMBH (FEI: 3026344444) has 1 FDA import refusal record(s) in our database, spanning from 6/13/2025 to 6/13/2025.

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. BERGFELD LASERTECH GMBH's FEI number is 3026344444.

What types of violations has BERGFELD LASERTECH GMBH received?

BERGFELD LASERTECH GMBH 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 BERGFELD LASERTECH GMBH come from?

All FDA import refusal data for BERGFELD LASERTECH 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.