ImportRefusal LogoImportRefusal

LASRAM LASER HANDELS GMBH

✅ Low Risk

FEI: 3003618829 • Offenbach Am Main, Hassia • GERMANY

FEI

FEI Number

3003618829

📍

Location

Offenbach Am Main, Hassia

🇩🇪

Country

GERMANY
🏢

Address

Jacques-Offenbach-Str. 20, , Offenbach Am Main, Hassia, Germany

Low Risk

FDA Import Risk Assessment

24.3
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

1
Total Refusals
3
Unique Violations
12/14/2001
Latest Refusal
12/14/2001
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
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

1181×

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).

3411×

REGISTERED

It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).

5081×

NO 510(K)

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.

Refusal History

DateProductViolationsDivision
12/14/2001
80LNXCOMPUTERS AND SOFTWARE, MEDICAL
118NOT LISTED
341REGISTERED
508NO 510(K)
New York District Office (NYK-DO)

Frequently Asked Questions

What is LASRAM LASER HANDELS GMBH's FDA import refusal history?

LASRAM LASER HANDELS GMBH (FEI: 3003618829) has 1 FDA import refusal record(s) in our database, spanning from 12/14/2001 to 12/14/2001.

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. LASRAM LASER HANDELS GMBH's FEI number is 3003618829.

What types of violations has LASRAM LASER HANDELS GMBH received?

LASRAM LASER HANDELS GMBH has been cited for 3 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 LASRAM LASER HANDELS GMBH come from?

All FDA import refusal data for LASRAM LASER HANDELS 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.