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Medart A /S

⚠️ Moderate Risk

FEI: 3005616124 • Hvidovre, Hovedstaden • DENMARK

FEI

FEI Number

3005616124

📍

Location

Hvidovre, Hovedstaden

🇩🇰

Country

DENMARK
🏢

Address

Industriholmen 15a, , Hvidovre, Hovedstaden, Denmark

Moderate Risk

FDA Import Risk Assessment

37.0
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
11/17/2005
Latest Refusal
9/12/2004
Earliest Refusal

Score Breakdown

Violation Severity
75.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
16.9×10%
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

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.

5081×

NO 510(K)

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.

Refusal History

DateProductViolationsDivision
11/17/2005
95L22LASER PRODUCT FOR NON-MEDICAL USE
126FAILS STD
New Orleans District Office (NOL-DO)
9/12/2004
79GEXPOWERED LASER SURGICAL INSTRUMENTS
508NO 510(K)
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Medart A /S's FDA import refusal history?

Medart A /S (FEI: 3005616124) has 2 FDA import refusal record(s) in our database, spanning from 9/12/2004 to 11/17/2005.

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. Medart A /S's FEI number is 3005616124.

What types of violations has Medart A /S received?

Medart A /S 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 Medart A /S come from?

All FDA import refusal data for Medart A /S 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.