S.U. A. Martin GmbH & Co. KG
⚠️ High Risk
FEI: 3000178338 • Rietheim-Weilheim, Baden-Wurttemberg • GERMANY
FEI Number
3000178338
Location
Rietheim-Weilheim, Baden-Wurttemberg
Country
GERMANYAddress
Uhlandstr. 17, , Rietheim-Weilheim, Baden-Wurttemberg, Germany
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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
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).
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.
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 |
|---|---|---|---|
| 4/4/2025 | 84HAERONGEUR, MANUAL | 237NO PMA | Division of Southeast Imports (DSEI) |
| 4/4/2025 | 84HAERONGEUR, MANUAL | 237NO PMA | Division of Southeast Imports (DSEI) |
| 4/4/2025 | 84HAERONGEUR, MANUAL | 237NO PMA | Division of Southeast Imports (DSEI) |
| 4/4/2025 | 84HAERONGEUR, MANUAL | 237NO PMA | Division of Southeast Imports (DSEI) |
| 4/4/2025 | 84HAERONGEUR, MANUAL | 237NO PMA | Division of Southeast Imports (DSEI) |
| 4/4/2025 | 84HAERONGEUR, MANUAL | 237NO PMA | Division of Southeast Imports (DSEI) |
| 4/4/2025 | 84HAERONGEUR, MANUAL | 237NO PMA | Division of Southeast Imports (DSEI) |
| 4/4/2025 | 84HAERONGEUR, MANUAL | 237NO PMA | Division of Southeast Imports (DSEI) |
| 4/4/2025 | 84HAERONGEUR, MANUAL | 237NO PMA | Division of Southeast Imports (DSEI) |
| 4/4/2025 | 84HAERONGEUR, MANUAL | 237NO PMA | Division of Southeast Imports (DSEI) |
| 4/4/2025 | 84HAERONGEUR, MANUAL | 237NO PMA | Division of Southeast Imports (DSEI) |
| 4/4/2025 | 84HAERONGEUR, MANUAL | 237NO PMA | Division of Southeast Imports (DSEI) |
| 6/7/2022 | 84HAERONGEUR, MANUAL | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 6/7/2022 | 84HAERONGEUR, MANUAL | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 6/7/2022 | 84HAERONGEUR, MANUAL | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 6/7/2022 | 84HAERONGEUR, MANUAL | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 9/15/2005 | 87HTXRONGEUR | 118NOT LISTED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is S.U. A. Martin GmbH & Co. KG's FDA import refusal history?
S.U. A. Martin GmbH & Co. KG (FEI: 3000178338) has 17 FDA import refusal record(s) in our database, spanning from 9/15/2005 to 4/4/2025.
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. S.U. A. Martin GmbH & Co. KG's FEI number is 3000178338.
What types of violations has S.U. A. Martin GmbH & Co. KG received?
S.U. A. Martin GmbH & Co. KG 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 S.U. A. Martin GmbH & Co. KG come from?
All FDA import refusal data for S.U. A. Martin GmbH & Co. KG 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.