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Nt-Trading Gmbh

✅ Low Risk

FEI: 3009557488 • Karlsruhe, Baden-Wurttemberg • GERMANY

FEI

FEI Number

3009557488

📍

Location

Karlsruhe, Baden-Wurttemberg

🇩🇪

Country

GERMANY
🏢

Address

G.-Braun-Str. 18, , Karlsruhe, Baden-Wurttemberg, Germany

Low Risk

FDA Import Risk Assessment

24.4
LowModerateHighCritical

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

Statistics

3
Total Refusals
2
Unique Violations
10/26/2020
Latest Refusal
8/17/2020
Earliest Refusal

Score Breakdown

Violation Severity
36.7×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
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

3412×

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).

32801×

FRNMFGREG

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.

Refusal History

DateProductViolationsDivision
10/26/2020
76NHAABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS
341REGISTERED
Division of Southeast Imports (DSEI)
10/2/2020
76NHAABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS
3280FRNMFGREG
Division of Southeast Imports (DSEI)
8/17/2020
76NHAABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS
341REGISTERED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Nt-Trading Gmbh's FDA import refusal history?

Nt-Trading Gmbh (FEI: 3009557488) has 3 FDA import refusal record(s) in our database, spanning from 8/17/2020 to 10/26/2020.

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. Nt-Trading Gmbh's FEI number is 3009557488.

What types of violations has Nt-Trading Gmbh received?

Nt-Trading 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 Nt-Trading Gmbh come from?

All FDA import refusal data for Nt-Trading 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.