Mystim Gmbh

⚠️ High Risk

FEI: 3009180723 • Mombris, Bayern • GERMANY

FEI

FEI Number

3009180723

📍

Location

Mombris, Bayern

🇩🇪

Country

GERMANY

🏢

Address

Konigsberger Str 26, , Mombris, Bayern, Germany

High Risk

FDA Import Risk Assessment

52.4

LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

Total Refusals

Unique Violations

3/4/2016

Latest Refusal

2/14/2013

Earliest Refusal

Score Breakdown

Violation Severity

63.4×40%

Refusal Volume

56.7×30%

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

11833×

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).

50831×

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.

23723×

NO PMA

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).

32803×

FRNMFGREG

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.

3413×

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
3/4/2016	84NFOSTIMULATOR, TRANSCUTANEOUS ELECTRICAL, FOR COSMETIC USE	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
2/3/2016	89IPFSTIMULATOR, MUSCLE, POWERED	118NOT LISTED	New Orleans District Office (NOL-DO)
7/21/2015	84NYXSTIMULATOR, ELECTRICAL, TRANSCUTANEOUS, WITH LIMTED OUTPUT, FOR AESTHETIC PURPOSES	118NOT LISTED 508NO 510(K)	Division of Southeast Imports (DSEI)
7/2/2015	84NFOSTIMULATOR, TRANSCUTANEOUS ELECTRICAL, FOR COSMETIC USE	118NOT LISTED 508NO 510(K)	Division of Southeast Imports (DSEI)
6/29/2015	84NFOSTIMULATOR, TRANSCUTANEOUS ELECTRICAL, FOR COSMETIC USE	118NOT LISTED 508NO 510(K)	Division of Southeast Imports (DSEI)
12/19/2014	79JOTELECTRODE, GEL, ELECTROSURGICAL	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)
12/19/2014	79JOTELECTRODE, GEL, ELECTROSURGICAL	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	New Orleans District Office (NOL-DO)
10/7/2014	85NUCLUBRICANT, PATIENT, VAGINAL, LATEX COMPATIBLE	118NOT LISTED 237NO PMA 508NO 510(K)	New Orleans District Office (NOL-DO)
10/7/2014	85HIISTIMULATOR, VAGINAL, MUSCLE, POWERED, FOR THERAPEUTIC USE	118NOT LISTED 237NO PMA 508NO 510(K)	New Orleans District Office (NOL-DO)
10/7/2014	85HIISTIMULATOR, VAGINAL, MUSCLE, POWERED, FOR THERAPEUTIC USE	118NOT LISTED 237NO PMA 508NO 510(K)	New Orleans District Office (NOL-DO)
10/7/2014	85HIISTIMULATOR, VAGINAL, MUSCLE, POWERED, FOR THERAPEUTIC USE	118NOT LISTED 237NO PMA 508NO 510(K)	New Orleans District Office (NOL-DO)
10/7/2014	85HIISTIMULATOR, VAGINAL, MUSCLE, POWERED, FOR THERAPEUTIC USE	118NOT LISTED 237NO PMA 508NO 510(K)	New Orleans District Office (NOL-DO)
10/7/2014	85HIISTIMULATOR, VAGINAL, MUSCLE, POWERED, FOR THERAPEUTIC USE	118NOT LISTED 237NO PMA 508NO 510(K)	New Orleans District Office (NOL-DO)
10/7/2014	85HIISTIMULATOR, VAGINAL, MUSCLE, POWERED, FOR THERAPEUTIC USE	118NOT LISTED 237NO PMA 508NO 510(K)	New Orleans District Office (NOL-DO)
10/7/2014	85HIISTIMULATOR, VAGINAL, MUSCLE, POWERED, FOR THERAPEUTIC USE	118NOT LISTED 237NO PMA 508NO 510(K)	New Orleans District Office (NOL-DO)
10/7/2014	85HIISTIMULATOR, VAGINAL, MUSCLE, POWERED, FOR THERAPEUTIC USE	118NOT LISTED 237NO PMA 508NO 510(K)	New Orleans District Office (NOL-DO)
10/7/2014	85HIISTIMULATOR, VAGINAL, MUSCLE, POWERED, FOR THERAPEUTIC USE	118NOT LISTED 237NO PMA 508NO 510(K)	New Orleans District Office (NOL-DO)
10/7/2014	85HIISTIMULATOR, VAGINAL, MUSCLE, POWERED, FOR THERAPEUTIC USE	118NOT LISTED 237NO PMA 508NO 510(K)	New Orleans District Office (NOL-DO)
10/7/2014	85HIISTIMULATOR, VAGINAL, MUSCLE, POWERED, FOR THERAPEUTIC USE	118NOT LISTED 237NO PMA 508NO 510(K)	New Orleans District Office (NOL-DO)
10/7/2014	85HIISTIMULATOR, VAGINAL, MUSCLE, POWERED, FOR THERAPEUTIC USE	118NOT LISTED 237NO PMA 508NO 510(K)	New Orleans District Office (NOL-DO)
10/7/2014	85HIISTIMULATOR, VAGINAL, MUSCLE, POWERED, FOR THERAPEUTIC USE	118NOT LISTED 237NO PMA 508NO 510(K)	New Orleans District Office (NOL-DO)
10/7/2014	85HIISTIMULATOR, VAGINAL, MUSCLE, POWERED, FOR THERAPEUTIC USE	118NOT LISTED 237NO PMA 508NO 510(K)	New Orleans District Office (NOL-DO)
10/7/2014	85HIISTIMULATOR, VAGINAL, MUSCLE, POWERED, FOR THERAPEUTIC USE	118NOT LISTED 237NO PMA 508NO 510(K)	New Orleans District Office (NOL-DO)
10/7/2014	85HIISTIMULATOR, VAGINAL, MUSCLE, POWERED, FOR THERAPEUTIC USE	118NOT LISTED 237NO PMA 508NO 510(K)	New Orleans District Office (NOL-DO)
10/7/2014	85HIISTIMULATOR, VAGINAL, MUSCLE, POWERED, FOR THERAPEUTIC USE	118NOT LISTED 237NO PMA 508NO 510(K)	New Orleans District Office (NOL-DO)
10/7/2014	85HIISTIMULATOR, VAGINAL, MUSCLE, POWERED, FOR THERAPEUTIC USE	118NOT LISTED 237NO PMA 508NO 510(K)	New Orleans District Office (NOL-DO)
10/7/2014	85HIISTIMULATOR, VAGINAL, MUSCLE, POWERED, FOR THERAPEUTIC USE	118NOT LISTED 237NO PMA 508NO 510(K)	New Orleans District Office (NOL-DO)
10/7/2014	85HIISTIMULATOR, VAGINAL, MUSCLE, POWERED, FOR THERAPEUTIC USE	118NOT LISTED 237NO PMA 508NO 510(K)	New Orleans District Office (NOL-DO)
10/7/2014	85HIISTIMULATOR, VAGINAL, MUSCLE, POWERED, FOR THERAPEUTIC USE	118NOT LISTED 237NO PMA 508NO 510(K)	New Orleans District Office (NOL-DO)
10/7/2014	85HIISTIMULATOR, VAGINAL, MUSCLE, POWERED, FOR THERAPEUTIC USE	118NOT LISTED 237NO PMA 508NO 510(K)	New Orleans District Office (NOL-DO)
2/14/2013	89IPFSTIMULATOR, MUSCLE, POWERED	118NOT LISTED 341REGISTERED 508NO 510(K)	New Orleans District Office (NOL-DO)
2/14/2013	89IPFSTIMULATOR, MUSCLE, POWERED	118NOT LISTED 341REGISTERED 508NO 510(K)	New Orleans District Office (NOL-DO)
2/14/2013	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	118NOT LISTED 341REGISTERED	New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Mystim Gmbh's FDA import refusal history?

Mystim Gmbh (FEI: 3009180723) has 33 FDA import refusal record(s) in our database, spanning from 2/14/2013 to 3/4/2016.

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. Mystim Gmbh's FEI number is 3009180723.

What types of violations has Mystim Gmbh received?

Mystim Gmbh has been cited for 5 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 Mystim Gmbh come from?

All FDA import refusal data for Mystim 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.