Allwin Medical Devices
⚠️ High Risk
FEI: 3006279007 • Surat, Gujarat • INDIA
FEI Number
3006279007
Location
Surat, Gujarat
Country
INDIAAddress
Plot No. 223, 230, Surat Special Economic Zone, Sachin, Surat, Gujarat, India
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable 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
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 |
|---|---|---|---|
| 4/8/2008 | 78FDISNARE, FLEXIBLE | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 4/8/2008 | 78FADSTENT, URETERAL | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 4/8/2008 | 78KOEDILATOR, URETHRAL | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 4/8/2008 | 85KNAINSTRUMENT, MANUAL, SPECIALIZED OBSTETRIC-GYNECOLOGIC | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 4/8/2008 | 78KNTTUBES, GASTROINTESTINAL (AND ACCESSORIES) | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 4/8/2008 | 78FHACLAMP, PENILE | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 4/8/2008 | 78FCLFORCEPS, BIOPSY, NON-ELECTRIC | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 4/8/2008 | 78FGODISLODGER, STONE, FLEXIBLE | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 4/8/2008 | 78KOEDILATOR, URETHRAL | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 4/8/2008 | 78EYBCATHETER, URETERAL, GASTRO-UROLOGY | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 4/8/2008 | 78OCYENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 4/8/2008 | 79DWONEEDLE, BIOPSY, CARDIOVASCULAR | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Allwin Medical Devices's FDA import refusal history?
Allwin Medical Devices (FEI: 3006279007) has 12 FDA import refusal record(s) in our database, spanning from 4/8/2008 to 4/8/2008.
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. Allwin Medical Devices's FEI number is 3006279007.
What types of violations has Allwin Medical Devices received?
Allwin Medical Devices has been cited for 1 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 Allwin Medical Devices come from?
All FDA import refusal data for Allwin 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.