Metron Handel Gmbh

⚠️ Moderate Risk

FEI: 3005720598 • Woergl • GERMANY

FEI

FEI Number

3005720598

📍

Location

Woergl

🇩🇪

Country

GERMANY

🏢

Address

Kanzler Biener Strasse 16, , Woergl, , Germany

Moderate Risk

FDA Import Risk Assessment

38.0

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

10/31/2006

Latest Refusal

10/31/2006

Earliest Refusal

Score Breakdown

Violation Severity

40.0×40%

Refusal Volume

40.0×30%

Recency

0.0×20%

Frequency

100.0×10%

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

Violation Summary

34110×

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).

5082×

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.

23801×

NO PMA/PDP

The article appears to be a class III dev.w/o an approved applic. for premarket approval, and/or a notice of completion of product development protocol filed per section 515(b) or exempt per sect.520(g)(1).

Refusal History

Date	Product	Violations	Division
10/31/2006	79KMFBANDAGE, LIQUID	2380NO PMA/PDP	Florida District Office (FLA-DO)
10/31/2006	79KMFBANDAGE, LIQUID	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
10/31/2006	79KMFBANDAGE, LIQUID	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
10/31/2006	79NADDRESSING, WOUND, OCCLUSIVE	341REGISTERED	Florida District Office (FLA-DO)
10/31/2006	80FMFSYRINGE, PISTON	341REGISTERED	Florida District Office (FLA-DO)
10/31/2006	80FMFSYRINGE, PISTON	341REGISTERED	Florida District Office (FLA-DO)
10/31/2006	79NADDRESSING, WOUND, OCCLUSIVE	341REGISTERED	Florida District Office (FLA-DO)
10/31/2006	89ITGBANDAGE, CAST	341REGISTERED	Florida District Office (FLA-DO)
10/31/2006	74DQDSTETHOSCOPE, ELECTRONIC	341REGISTERED	Florida District Office (FLA-DO)
10/31/2006	80FQMBANDAGE, ELASTIC	341REGISTERED	Florida District Office (FLA-DO)
10/31/2006	80FQMBANDAGE, ELASTIC	341REGISTERED	Florida District Office (FLA-DO)

Frequently Asked Questions

What is Metron Handel Gmbh's FDA import refusal history?

Metron Handel Gmbh (FEI: 3005720598) has 11 FDA import refusal record(s) in our database, spanning from 10/31/2006 to 10/31/2006.

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. Metron Handel Gmbh's FEI number is 3005720598.

What types of violations has Metron Handel Gmbh received?

Metron Handel Gmbh 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 Metron Handel Gmbh come from?

All FDA import refusal data for Metron Handel 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.