Indomed Hearing Systems Gmbh
⚠️ Moderate Risk
FEI: 3007238129 • Stafa, Zurich • SWITZERLAND
FEI Number
3007238129
Location
Stafa, Zurich
Country
SWITZERLANDAddress
Laubisrutistrasse 28, , Stafa, Zurich, Switzerland
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
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
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).
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 |
|---|---|---|---|
| 7/25/2011 | 77ESDHEARING-AID, AIR-CONDUCTION | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 7/25/2011 | 77KHLHEARING-AID, MASTER | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 5/24/2011 | 77ESDHEARING-AID, AIR-CONDUCTION | 118NOT LISTED | New York District Office (NYK-DO) |
| 2/28/2011 | 77ESDHEARING-AID, AIR-CONDUCTION | New York District Office (NYK-DO) | |
| 2/28/2011 | 77ESDHEARING-AID, AIR-CONDUCTION | New York District Office (NYK-DO) | |
| 12/16/2010 | 77ESDHEARING-AID, AIR-CONDUCTION | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Indomed Hearing Systems Gmbh's FDA import refusal history?
Indomed Hearing Systems Gmbh (FEI: 3007238129) has 6 FDA import refusal record(s) in our database, spanning from 12/16/2010 to 7/25/2011.
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. Indomed Hearing Systems Gmbh's FEI number is 3007238129.
What types of violations has Indomed Hearing Systems Gmbh received?
Indomed Hearing Systems Gmbh 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 Indomed Hearing Systems Gmbh come from?
All FDA import refusal data for Indomed Hearing Systems 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.