Uab Telemed
✅ Low Risk
FEI: 3004767743 • Vilnius, Vilnius County • LITHUANIA
FEI Number
3004767743
Location
Vilnius, Vilnius County
Country
LITHUANIAAddress
Dariaus Ir Gireno G. 11 42, , Vilnius, Vilnius County, Lithuania
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity 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
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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(o) in that it is being imported or offered for import into the United States, and the importer, owner, or consignee of such article did not, at the time of offering the article for import, submit to the Secretary a statement that identifies the registration under section 510(i) of the Act of each establishment that with respect to such article is required under such section to register with the Secretary.
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 |
|---|---|---|---|
| 1/13/2014 | 90IYNSYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC | Division of Northern Border Imports (DNBI) | |
| 9/13/2005 | 79NRJULTRASOUND, SKIN PERMEATION | 508NO 510(K) | New Orleans District Office (NOL-DO) |
| 7/2/2004 | 80FLGCLEANER, ULTRASONIC, MEDICAL INSTRUMENT | 341REGISTERED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Uab Telemed's FDA import refusal history?
Uab Telemed (FEI: 3004767743) has 3 FDA import refusal record(s) in our database, spanning from 7/2/2004 to 1/13/2014.
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. Uab Telemed's FEI number is 3004767743.
What types of violations has Uab Telemed received?
Uab Telemed 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 Uab Telemed come from?
All FDA import refusal data for Uab Telemed 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.