ALLWIN MEDICAL DEVICES
✅ Low Risk
FEI: 3017512429 • Surat, Gujarat • INDIA
FEI Number
3017512429
Location
Surat, Gujarat
Country
INDIAAddress
230 - 221 Plot # 223, City Light Road, Surat, Gujarat, India
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/17/2021 | 85MQENEEDLE, ASSISTED REPRODUCTION | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 12/17/2021 | 85MQFCATHETER, ASSISTED REPRODUCTION | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 12/17/2021 | 85MQFCATHETER, ASSISTED REPRODUCTION | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 12/17/2021 | 85MQENEEDLE, ASSISTED REPRODUCTION | 341REGISTERED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is ALLWIN MEDICAL DEVICES's FDA import refusal history?
ALLWIN MEDICAL DEVICES (FEI: 3017512429) has 4 FDA import refusal record(s) in our database, spanning from 12/17/2021 to 12/17/2021.
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 3017512429.
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.