Degania Medical Devices Pvt. Ltd.
⚠️ Moderate Risk
FEI: 3005483737 • Gurgaon, Haryana • INDIA
FEI Number
3005483737
Location
Gurgaon, Haryana
Country
INDIAAddress
Plot No 251, Imt Manesar, Gurgaon, Haryana, India
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/31/2019 | 79OTKWOUND DRAIN CATHETER SYSTEM | 508NO 510(K) | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is Degania Medical Devices Pvt. Ltd.'s FDA import refusal history?
Degania Medical Devices Pvt. Ltd. (FEI: 3005483737) has 1 FDA import refusal record(s) in our database, spanning from 1/31/2019 to 1/31/2019.
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. Degania Medical Devices Pvt. Ltd.'s FEI number is 3005483737.
What types of violations has Degania Medical Devices Pvt. Ltd. received?
Degania Medical Devices Pvt. Ltd. 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 Degania Medical Devices Pvt. Ltd. come from?
All FDA import refusal data for Degania Medical Devices Pvt. 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.