COCUNAT S.L
⚠️ High Risk
FEI: 3025416426 • Barcelona • 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
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.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/8/2025 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | Division of West Coast Imports (DWCI) | |
| 9/19/2025 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | Division of Southeast Imports (DSEI) | |
| 9/18/2025 | 79QAIPOWERED MICRONEEDLE DEVICE | Division of Southeast Imports (DSEI) | |
| 6/3/2025 | 79QAIPOWERED MICRONEEDLE DEVICE | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is COCUNAT S.L's FDA import refusal history?
COCUNAT S.L (FEI: 3025416426) has 4 FDA import refusal record(s) in our database, spanning from 6/3/2025 to 10/8/2025.
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. COCUNAT S.L's FEI number is 3025416426.
What types of violations has COCUNAT S.L received?
COCUNAT S.L has been cited for 4 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 COCUNAT S.L come from?
All FDA import refusal data for COCUNAT S.L 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.