Hebumedical GMBH
⚠️ Moderate Risk
FEI: 3008782585 • Tuttlingen, Baden-Wurttemberg • GERMANY
FEI Number
3008782585
Location
Tuttlingen, Baden-Wurttemberg
Country
GERMANYAddress
Badstr. 8, , Tuttlingen, Baden-Wurttemberg, 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/29/2019 | 77KTGKNIFE, ENT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 7/23/2015 | 80KCTSTERILIZATION WRAP CONTAINERS, TRAYS, CASSETTES & OTHER ACCESSORIES | 118NOT LISTED | Atlanta District Office (ATL-DO) |
| 1/31/2007 | 77KTFPUNCH, ENT | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 1/31/2007 | 77KAEFORCEPS, ENT | 118NOT LISTED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Hebumedical GMBH's FDA import refusal history?
Hebumedical GMBH (FEI: 3008782585) has 4 FDA import refusal record(s) in our database, spanning from 1/31/2007 to 3/29/2019.
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. Hebumedical GMBH's FEI number is 3008782585.
What types of violations has Hebumedical GMBH received?
Hebumedical GMBH has been cited for 1 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 Hebumedical GMBH come from?
All FDA import refusal data for Hebumedical 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.