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Asap Endoscopic Pr

⚠️ Moderate Risk

FEI: 3007771384 • Umkirch, Baden-wuerttemberg • GERMANY

FEI

FEI Number

3007771384

📍

Location

Umkirch, Baden-wuerttemberg

🇩🇪

Country

GERMANY
🏢

Address

Stockmatten 19, , Umkirch, Baden-wuerttemberg, Germany

Moderate Risk

FDA Import Risk Assessment

33.6
LowModerateHighCritical

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

Statistics

5
Total Refusals
1
Unique Violations
9/9/2011
Latest Refusal
9/9/2011
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
28.8×30%
Recency
0.0×20%
Frequency
50.0×10%
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

1185×

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
9/9/2011
79HTDFORCEPS
118NOT LISTED
New Orleans District Office (NOL-DO)
9/9/2011
78FEDSHEATH, FOR ENDOSCOPE
118NOT LISTED
New Orleans District Office (NOL-DO)
9/9/2011
78FAHDILATOR, URETHRAL, MECHANICAL
118NOT LISTED
New Orleans District Office (NOL-DO)
9/9/2011
80KZHINTRODUCER, SYRINGE NEEDLE
118NOT LISTED
New Orleans District Office (NOL-DO)
9/9/2011
78FAJCYSTOSCOPE, DIAGNOSTIC
118NOT LISTED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Asap Endoscopic Pr's FDA import refusal history?

Asap Endoscopic Pr (FEI: 3007771384) has 5 FDA import refusal record(s) in our database, spanning from 9/9/2011 to 9/9/2011.

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. Asap Endoscopic Pr's FEI number is 3007771384.

What types of violations has Asap Endoscopic Pr received?

Asap Endoscopic Pr 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 Asap Endoscopic Pr come from?

All FDA import refusal data for Asap Endoscopic Pr 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.