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Venus Medical

⚠️ Moderate Risk

FEI: 3007802879 • Amsterdam, Noord-holland • NETHERLANDS

FEI

FEI Number

3007802879

📍

Location

Amsterdam, Noord-holland

🇳🇱
🏢

Address

Ruyschstraat 68, , Amsterdam, Noord-holland, Netherlands

Moderate Risk

FDA Import Risk Assessment

32.7
LowModerateHighCritical

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

Statistics

3
Total Refusals
2
Unique Violations
2/17/2010
Latest Refusal
9/18/2009
Earliest Refusal

Score Breakdown

Violation Severity
57.5×40%
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

1183×

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).

1261×

FAILS STD

The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.

Refusal History

DateProductViolationsDivision
2/17/2010
89ISAMASSAGER, THERAPEUTIC, ELECTRIC
118NOT LISTED
Cincinnati District Office (CIN-DO)
10/13/2009
89ISAMASSAGER, THERAPEUTIC, ELECTRIC
118NOT LISTED
126FAILS STD
Cincinnati District Office (CIN-DO)
9/18/2009
89ISAMASSAGER, THERAPEUTIC, ELECTRIC
118NOT LISTED
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Venus Medical's FDA import refusal history?

Venus Medical (FEI: 3007802879) has 3 FDA import refusal record(s) in our database, spanning from 9/18/2009 to 2/17/2010.

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. Venus Medical's FEI number is 3007802879.

What types of violations has Venus Medical received?

Venus Medical 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 Venus Medical come from?

All FDA import refusal data for Venus Medical 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.