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Laserscope (Uk) Ltd

⚠️ Moderate Risk

FEI: 3001555280 • Cwmbran Gwent Wales • UNITED KINGDOM

FEI

FEI Number

3001555280

📍

Location

Cwmbran Gwent Wales

🇬🇧
🏢

Address

Raglan House Llantarnam, , Cwmbran Gwent Wales, , United Kingdom

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
10/15/2001
Latest Refusal
10/15/2001
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
10/15/2001
95L22LASER PRODUCT FOR NON-MEDICAL USE
476NO REGISTR
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Laserscope (Uk) Ltd's FDA import refusal history?

Laserscope (Uk) Ltd (FEI: 3001555280) has 1 FDA import refusal record(s) in our database, spanning from 10/15/2001 to 10/15/2001.

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. Laserscope (Uk) Ltd's FEI number is 3001555280.

What types of violations has Laserscope (Uk) Ltd received?

Laserscope (Uk) Ltd 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 Laserscope (Uk) Ltd come from?

All FDA import refusal data for Laserscope (Uk) Ltd 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.