Ecleris S.R.L.

⚠️ Moderate Risk

FEI: 3007740520 • Villa Martelli, Buenos Aires • ARGENTINA

FEI

FEI Number

3007740520

📍

Location

Villa Martelli, Buenos Aires

🇦🇷

Country

ARGENTINA

🏢

Address

Calle Francisco De Laprida 4955, , Villa Martelli, Buenos Aires, Argentina

Moderate Risk

FDA Import Risk Assessment

31.6

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

3/21/2017

Latest Refusal

11/14/2013

Earliest Refusal

Score Breakdown

Violation Severity

51.2×40%

Refusal Volume

31.3×30%

Recency

0.0×20%

Frequency

17.9×10%

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

Violation Summary

1186×

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).

5086×

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.

3415×

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).

Refusal History

Date	Product	Violations	Division
3/21/2017	79OHVFOCUSED ULTRASOUND FOR TISSUE HEAT OR MECHANICAL CELLULAR DISRUPTION	118NOT LISTED 508NO 510(K)	Division of Southeast Imports (DSEI)
11/14/2013	79GEXPOWERED LASER SURGICAL INSTRUMENTS	118NOT LISTED 341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
11/14/2013	79GEXPOWERED LASER SURGICAL INSTRUMENTS	118NOT LISTED 341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
11/14/2013	79GEXPOWERED LASER SURGICAL INSTRUMENTS	118NOT LISTED 341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
11/14/2013	79GEXPOWERED LASER SURGICAL INSTRUMENTS	118NOT LISTED 341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
11/14/2013	79GEXPOWERED LASER SURGICAL INSTRUMENTS	118NOT LISTED 341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)

Frequently Asked Questions

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

Ecleris S.R.L. (FEI: 3007740520) has 6 FDA import refusal record(s) in our database, spanning from 11/14/2013 to 3/21/2017.

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. Ecleris S.R.L.'s FEI number is 3007740520.

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

Ecleris S.R.L. has been cited for 3 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 Ecleris S.R.L. come from?

All FDA import refusal data for Ecleris 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.