Coherent Lasersystems Gmbh & Co Kg-Gottingen
⚠️ High Risk
FEI: 3005289560 • Gottingen, Lower Saxony • GERMANY
FEI Number
3005289560
Location
Gottingen, Lower Saxony
Country
GERMANYAddress
Hans-Bockler-Str. 12, , Gottingen, Lower Saxony, Germany
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
Statistics
Score Breakdown
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
FAILS STD
The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/22/2025 | 95RDWGENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL | 126FAILS STD | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Coherent Lasersystems Gmbh & Co Kg-Gottingen's FDA import refusal history?
Coherent Lasersystems Gmbh & Co Kg-Gottingen (FEI: 3005289560) has 1 FDA import refusal record(s) in our database, spanning from 4/22/2025 to 4/22/2025.
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. Coherent Lasersystems Gmbh & Co Kg-Gottingen's FEI number is 3005289560.
What types of violations has Coherent Lasersystems Gmbh & Co Kg-Gottingen received?
Coherent Lasersystems Gmbh & Co Kg-Gottingen 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 Lasersystems Gmbh & Co Kg-Gottingen come from?
All FDA import refusal data for Coherent Lasersystems Gmbh & Co Kg-Gottingen 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.