Invendo Medical Gmbh

⚠️ Moderate Risk

FEI: 3005728562 • Kissing, Bavaria • GERMANY

FEI

FEI Number

3005728562

📍

Location

Kissing, Bavaria

🇩🇪

Country

GERMANY

🏢

Address

Peterhofstr. 3 B, , Kissing, Bavaria, Germany

Moderate Risk

FDA Import Risk Assessment

33.6

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

6/11/2009

Latest Refusal

6/11/2009

Earliest Refusal

Score Breakdown

Violation Severity

50.0×40%

Refusal Volume

28.8×30%

Recency

0.0×20%

Frequency

50.0×10%

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

1185×

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).

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).

5085×

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

Date	Product	Violations	Division
6/11/2009	78FCLFORCEPS, BIOPSY, NON-ELECTRIC	118NOT LISTED 341REGISTERED 508NO 510(K)	Chicago District Office (CHI-DO)
6/11/2009	78GCPENDOSCOPE, AC-POWERED AND ACCESSORIES	118NOT LISTED 341REGISTERED 508NO 510(K)	Chicago District Office (CHI-DO)
6/11/2009	78GCPENDOSCOPE, AC-POWERED AND ACCESSORIES	118NOT LISTED 341REGISTERED 508NO 510(K)	Chicago District Office (CHI-DO)
6/11/2009	78GCPENDOSCOPE, AC-POWERED AND ACCESSORIES	118NOT LISTED 341REGISTERED 508NO 510(K)	Chicago District Office (CHI-DO)
6/11/2009	78GCPENDOSCOPE, AC-POWERED AND ACCESSORIES	118NOT LISTED 341REGISTERED 508NO 510(K)	Chicago District Office (CHI-DO)

Frequently Asked Questions

What is Invendo Medical Gmbh's FDA import refusal history?

Invendo Medical Gmbh (FEI: 3005728562) has 5 FDA import refusal record(s) in our database, spanning from 6/11/2009 to 6/11/2009.

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. Invendo Medical Gmbh's FEI number is 3005728562.

What types of violations has Invendo Medical Gmbh received?

Invendo Medical 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 Invendo Medical Gmbh come from?

All FDA import refusal data for Invendo Medical 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.