QualiMed Innovative Medizinprodukte GmbH
⚠️ Moderate Risk
FEI: 3004193137 • Winsen (Luhe), Lower Saxony • GERMANY
FEI Number
3004193137
Location
Winsen (Luhe), Lower Saxony
Country
GERMANYAddress
Boschstr. 16, , Winsen (Luhe), Lower Saxony, Germany
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.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/7/2020 | 80FOZCATHETER, INTRAVASCULAR, SHORT TERM | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 6/12/2020 | 74NIQSTENT, CORONARY, DRUG-ELUTING | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 1/9/2020 | 74NIQSTENT, CORONARY, DRUG-ELUTING | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 10/25/2019 | 74NIQSTENT, CORONARY, DRUG-ELUTING | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 5/15/2019 | 74NIQSTENT, CORONARY, DRUG-ELUTING | Division of Southeast Imports (DSEI) | |
| 3/11/2019 | 74NIQSTENT, CORONARY, DRUG-ELUTING | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 6/13/2002 | 77FWNPROSTHESIS, LARYNX (STENTS AND KEELS) | 508NO 510(K) | New Orleans District Office (NOL-DO) |
| 4/30/2002 | 77FWNPROSTHESIS, LARYNX (STENTS AND KEELS) | 508NO 510(K) | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is QualiMed Innovative Medizinprodukte GmbH's FDA import refusal history?
QualiMed Innovative Medizinprodukte GmbH (FEI: 3004193137) has 8 FDA import refusal record(s) in our database, spanning from 4/30/2002 to 7/7/2020.
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. QualiMed Innovative Medizinprodukte GmbH's FEI number is 3004193137.
What types of violations has QualiMed Innovative Medizinprodukte GmbH received?
QualiMed Innovative Medizinprodukte 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 QualiMed Innovative Medizinprodukte GmbH come from?
All FDA import refusal data for QualiMed Innovative Medizinprodukte 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.