Intersurgical Uab
⚠️ Moderate Risk
FEI: 3002807293 • Papbrade • LITHUANIA
FEI Number
3002807293
Location
Papbrade
Country
LITHUANIAAddress
Arnioniu 60/28-1, , Papbrade, , Lithuania
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
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 |
|---|---|---|---|
| 3/9/2010 | 73CBPVALVE, NON-REBREATHING | 508NO 510(K) | New York District Office (NYK-DO) |
| 3/9/2010 | 73BZEHEATER, BREATHING SYSTEM W/WO CONTROLLER (NOT HUMIDIFIER OR NEBULIZER | 508NO 510(K) | New York District Office (NYK-DO) |
| 1/26/2010 | 73BTTHUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE) | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Intersurgical Uab's FDA import refusal history?
Intersurgical Uab (FEI: 3002807293) has 3 FDA import refusal record(s) in our database, spanning from 1/26/2010 to 3/9/2010.
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. Intersurgical Uab's FEI number is 3002807293.
What types of violations has Intersurgical Uab received?
Intersurgical Uab has been cited for 2 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 Intersurgical Uab come from?
All FDA import refusal data for Intersurgical Uab 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.