Unomedical A/S
⚠️ Moderate Risk
FEI: 1000477110 • Lejre, Sjalland • DENMARK
FEI Number
1000477110
Location
Lejre, Sjalland
Country
DENMARKAddress
Osted, Aholmvej 1 - 3, Lejre, Sjalland, Denmark
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
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 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 |
|---|---|---|---|
| 5/26/2023 | 79JCYCATHETER, INFUSION | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 7/29/2021 | 80FPASET, ADMINISTRATION, INTRAVASCULAR | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 7/29/2021 | 80FPASET, ADMINISTRATION, INTRAVASCULAR | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 7/29/2021 | 80FPASET, ADMINISTRATION, INTRAVASCULAR | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 7/29/2021 | 80FPASET, ADMINISTRATION, INTRAVASCULAR | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 4/10/2021 | 80FOZCATHETER, INTRAVASCULAR, SHORT TERM | Division of Southeast Imports (DSEI) | |
| 5/12/2011 | 80FPASET, ADMINISTRATION, INTRAVASCULAR | 341REGISTERED | Cincinnati District Office (CIN-DO) |
| 5/12/2011 | 80FPASET, ADMINISTRATION, INTRAVASCULAR | 341REGISTERED | Cincinnati District Office (CIN-DO) |
| 5/31/2005 | 80LZGPUMP, INFUSION, INSULIN | 508NO 510(K) | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Unomedical A/S's FDA import refusal history?
Unomedical A/S (FEI: 1000477110) has 9 FDA import refusal record(s) in our database, spanning from 5/31/2005 to 5/26/2023.
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. Unomedical A/S's FEI number is 1000477110.
What types of violations has Unomedical A/S received?
Unomedical A/S 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 Unomedical A/S come from?
All FDA import refusal data for Unomedical A/S 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.