Clearstream Technologies Ltd
⚠️ Moderate Risk
FEI: 3008906816 • Enniscorthy, Co. WEXFORD • IRELAND
FEI Number
3008906816
Location
Enniscorthy, Co. WEXFORD
Country
IRELANDAddress
19 Commodore Barry Park, , Enniscorthy, Co. WEXFORD, Ireland
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
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).
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.
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).
DEVICEGMPS
The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of the device do not conform to the requirements of Section 520(f)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or a condition prescribed by an order under section 520(f)(2) of the FD&C Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/6/2022 | 74LITCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL | 2780DEVICEGMPS | Division of Southeast Imports (DSEI) |
| 11/18/2019 | 74NIOSTENT, ILIAC | 237NO PMA | Division of Southeast Imports (DSEI) |
| 9/28/2018 | 74DQYCATHETER, PERCUTANEOUS | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 12/16/2014 | 74DSYPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER | Southwest Import District Office (SWI-DO) | |
| 12/16/2014 | 74DSYPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER | Southwest Import District Office (SWI-DO) | |
| 12/16/2014 | 74DSYPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER | Southwest Import District Office (SWI-DO) | |
| 12/16/2014 | 74DSYPROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER | Southwest Import District Office (SWI-DO) | |
| 3/28/2005 | 74LITCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL | New York District Office (NYK-DO) | |
| 8/23/2004 | 74DQRCANNULA, CATHETER | 508NO 510(K) | New Orleans District Office (NOL-DO) |
| 7/12/2004 | 74LOXCATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS & OPERATIVE | New Orleans District Office (NOL-DO) | |
| 7/3/2003 | 74LITCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL | 237NO PMA | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Clearstream Technologies Ltd's FDA import refusal history?
Clearstream Technologies Ltd (FEI: 3008906816) has 11 FDA import refusal record(s) in our database, spanning from 7/3/2003 to 5/6/2022.
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. Clearstream Technologies Ltd's FEI number is 3008906816.
What types of violations has Clearstream Technologies Ltd received?
Clearstream Technologies Ltd has been cited for 5 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 Clearstream Technologies Ltd come from?
All FDA import refusal data for Clearstream Technologies Ltd 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.