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ASANUS MEDIZINTECHNIK GMBH

⚠️ Moderate Risk

FEI: 3003772581 • Neuhausen Obeck, Baden-Wurttemberg • GERMANY

FEI

FEI Number

3003772581

📍

Location

Neuhausen Obeck, Baden-Wurttemberg

🇩🇪

Country

GERMANY
🏢

Address

GEWERBEPARK 2, , Neuhausen Obeck, Baden-Wurttemberg, Germany

Moderate Risk

FDA Import Risk Assessment

43.7
LowModerateHighCritical

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

Statistics

16
Total Refusals
1
Unique Violations
11/15/2010
Latest Refusal
11/15/2010
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
45.6×30%
Recency
0.0×20%
Frequency
100.0×10%
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

11816×

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).

Refusal History

DateProductViolationsDivision
11/15/2010
79HTDFORCEPS
118NOT LISTED
New Orleans District Office (NOL-DO)
11/15/2010
79HTDFORCEPS
118NOT LISTED
New Orleans District Office (NOL-DO)
11/15/2010
79HTDFORCEPS
118NOT LISTED
New Orleans District Office (NOL-DO)
11/15/2010
79HTDFORCEPS
118NOT LISTED
New Orleans District Office (NOL-DO)
11/15/2010
79HTDFORCEPS
118NOT LISTED
New Orleans District Office (NOL-DO)
11/15/2010
79HXDCLAMP
118NOT LISTED
New Orleans District Office (NOL-DO)
11/15/2010
79MDMINSTRUMENT, MANUAL, GENERAL SURGICAL
118NOT LISTED
New Orleans District Office (NOL-DO)
11/15/2010
79MDMINSTRUMENT, MANUAL, GENERAL SURGICAL
118NOT LISTED
New Orleans District Office (NOL-DO)
11/15/2010
79HTDFORCEPS
118NOT LISTED
New Orleans District Office (NOL-DO)
11/15/2010
79HTDFORCEPS
118NOT LISTED
New Orleans District Office (NOL-DO)
11/15/2010
79HXDCLAMP
118NOT LISTED
New Orleans District Office (NOL-DO)
11/15/2010
78FHQHOLDER, NEEDLE
118NOT LISTED
New Orleans District Office (NOL-DO)
11/15/2010
78FHQHOLDER, NEEDLE
118NOT LISTED
New Orleans District Office (NOL-DO)
11/15/2010
78FHQHOLDER, NEEDLE
118NOT LISTED
New Orleans District Office (NOL-DO)
11/15/2010
79LRWSCISSORS, GENERAL USE, SURGICAL
118NOT LISTED
New Orleans District Office (NOL-DO)
11/15/2010
79LRWSCISSORS, GENERAL USE, SURGICAL
118NOT LISTED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is ASANUS MEDIZINTECHNIK GMBH's FDA import refusal history?

ASANUS MEDIZINTECHNIK GMBH (FEI: 3003772581) has 16 FDA import refusal record(s) in our database, spanning from 11/15/2010 to 11/15/2010.

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. ASANUS MEDIZINTECHNIK GMBH's FEI number is 3003772581.

What types of violations has ASANUS MEDIZINTECHNIK GMBH received?

ASANUS MEDIZINTECHNIK GMBH 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 ASANUS MEDIZINTECHNIK GMBH come from?

All FDA import refusal data for ASANUS MEDIZINTECHNIK 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.