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Cosmed S.R.L.

✅ Low Risk

FEI: 2995 • Roma • ITALY

FEI

FEI Number

2995

📍

Location

Roma

🇮🇹

Country

ITALY
🏢

Address

Savello 37, Via Dei Piani Di Monte, Pavona Di Albano,, Roma, Italy

Low Risk

FDA Import Risk Assessment

24.5
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

2
Total Refusals
2
Unique Violations
5/12/2006
Latest Refusal
4/22/2005
Earliest Refusal

Score Breakdown

Violation Severity
43.3×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
19.0×10%
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

3412×

REGISTERED

It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).

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
5/12/2006
73BZCCALCULATOR, PULMONARY FUNCTION DATA
341REGISTERED
Chicago District Office (CHI-DO)
4/22/2005
90NRRLUNG COMPUTED TOMOGRAPHY SYSTEM, COMPUTER-AIDED DIAGNOSIS
341REGISTERED
508NO 510(K)
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Cosmed S.R.L.'s FDA import refusal history?

Cosmed S.R.L. (FEI: 2995) has 2 FDA import refusal record(s) in our database, spanning from 4/22/2005 to 5/12/2006.

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. Cosmed S.R.L.'s FEI number is 2995.

What types of violations has Cosmed S.R.L. received?

Cosmed S.R.L. 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 Cosmed S.R.L. come from?

All FDA import refusal data for Cosmed S.R.L. 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.