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CNSAC MEDSHOP GMBH

⚠️ Moderate Risk

FEI: 3030422102 • Theilheim • GERMANY

FEI

FEI Number

3030422102

📍

Location

Theilheim

🇩🇪

Country

GERMANY
🏢

Address

Biebelrieder Str, , Theilheim, , Germany

Moderate Risk

FDA Import Risk Assessment

43.1
LowModerateHighCritical

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

Statistics

2
Total Refusals
1
Unique Violations
9/11/2025
Latest Refusal
9/24/2024
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
17.7×30%
Recency
78.9×20%
Frequency
20.0×10%
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

1182×

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
9/11/2025
84GXYELECTRODE, CUTANEOUS
118NOT LISTED
Division of Southeast Imports (DSEI)
9/24/2024
74DRXELECTRODE, ELECTROCARDIOGRAPH
118NOT LISTED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is CNSAC MEDSHOP GMBH's FDA import refusal history?

CNSAC MEDSHOP GMBH (FEI: 3030422102) has 2 FDA import refusal record(s) in our database, spanning from 9/24/2024 to 9/11/2025.

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. CNSAC MEDSHOP GMBH's FEI number is 3030422102.

What types of violations has CNSAC MEDSHOP GMBH received?

CNSAC MEDSHOP 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 CNSAC MEDSHOP GMBH come from?

All FDA import refusal data for CNSAC MEDSHOP 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.