ANDROMEDICAL SL
⚠️ High Risk
FEI: 3006891790 • Madrid, Madrid • SPAIN
FEI Number
3006891790
Location
Madrid, Madrid
Country
SPAINAddress
Calle Procion 7, , Madrid, Madrid, Spain
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 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.
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
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).
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).
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).
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.
3905
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
NUTRIT LBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/4/2025 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 3/4/2025 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 4/16/2024 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | Division of Southeast Imports (DSEI) | |
| 7/21/2023 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | Division of Southeast Imports (DSEI) | |
| 7/18/2023 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | 508NO 510(K) | Division of Northeast Imports (DNEI) |
| 7/7/2023 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | 508NO 510(K) | Division of Northeast Imports (DNEI) |
| 1/5/2023 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | 508NO 510(K) | Division of Northeast Imports (DNEI) |
| 4/26/2022 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | 508NO 510(K) | Division of Northeast Imports (DNEI) |
| 4/15/2022 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | 508NO 510(K) | Division of Northeast Imports (DNEI) |
| 4/15/2022 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | 508NO 510(K) | Division of Northeast Imports (DNEI) |
| 1/31/2022 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | Division of Southeast Imports (DSEI) | |
| 4/28/2021 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 4/28/2021 | 54FYF99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Division of Southeast Imports (DSEI) | |
| 4/14/2021 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 3/19/2021 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 5/2/2013 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | Los Angeles District Office (LOS-DO) | |
| 6/1/2012 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | Division of Southeast Imports (DSEI) | |
| 5/2/2012 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | New Orleans District Office (NOL-DO) | |
| 5/18/2011 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | 237NO PMA | Philadelphia District Office (PHI-DO) |
| 5/17/2011 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | New York District Office (NYK-DO) | |
| 5/17/2011 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | Cincinnati District Office (CIN-DO) | |
| 5/10/2011 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | Cincinnati District Office (CIN-DO) | |
| 5/9/2011 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | 237NO PMA | Philadelphia District Office (PHI-DO) |
| 5/6/2011 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | Cincinnati District Office (CIN-DO) | |
| 4/17/2009 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is ANDROMEDICAL SL's FDA import refusal history?
ANDROMEDICAL SL (FEI: 3006891790) has 25 FDA import refusal record(s) in our database, spanning from 4/17/2009 to 3/4/2025.
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. ANDROMEDICAL SL's FEI number is 3006891790.
What types of violations has ANDROMEDICAL SL received?
ANDROMEDICAL SL has been cited for 9 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 ANDROMEDICAL SL come from?
All FDA import refusal data for ANDROMEDICAL SL 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.