Creganna Medical Devices
⚠️ Moderate Risk
FEI: 3004193842 • Galway, Co. GALWAY • IRELAND
FEI Number
3004193842
Location
Galway, Co. GALWAY
Country
IRELANDAddress
Parkmore House, Mweeloon, Galway, Co. GALWAY, 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).
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).
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(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 |
|---|---|---|---|
| 4/11/2017 | 74DQYCATHETER, PERCUTANEOUS | 237NO PMA | Division of Southeast Imports (DSEI) |
| 7/15/2016 | 74MAFSTENT, CARDIOVASCULAR | 341REGISTERED | Division of Northeast Imports (DNEI) |
| 4/20/2016 | 74DYBINTRODUCER, CATHETER | Los Angeles District Office (LOS-DO) | |
| 4/20/2016 | 74DYBINTRODUCER, CATHETER | Los Angeles District Office (LOS-DO) | |
| 4/20/2016 | 74DYBINTRODUCER, CATHETER | Los Angeles District Office (LOS-DO) | |
| 9/4/2014 | 78OCYENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY | New York District Office (NYK-DO) | |
| 5/24/2009 | 74LITCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL | 341REGISTERED | New Orleans District Office (NOL-DO) |
| 5/16/2002 | 80LDQDEVICE, GENERAL MEDICAL | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 1/8/2002 | 74MAFSTENT, CARDIOVASCULAR | 237NO PMA | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Creganna Medical Devices's FDA import refusal history?
Creganna Medical Devices (FEI: 3004193842) has 9 FDA import refusal record(s) in our database, spanning from 1/8/2002 to 4/11/2017.
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. Creganna Medical Devices's FEI number is 3004193842.
What types of violations has Creganna Medical Devices received?
Creganna Medical Devices 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 Creganna Medical Devices come from?
All FDA import refusal data for Creganna Medical Devices 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.