Ms Surgimedk Healthcare
⚠️ High Risk
FEI: 3007632112 • Sachin Surat, Gujarat • INDIA
FEI Number
3007632112
Location
Sachin Surat, Gujarat
Country
INDIAAddress
Plot No 223, , 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 |
|---|---|---|---|
| 8/19/2009 | 78FFLDISLODGER, STONE, BASKET, URETERAL, METAL | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 8/19/2009 | 78KNTTUBES, GASTROINTESTINAL (AND ACCESSORIES) | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 8/19/2009 | 78KOGENDOSCOPE AND/OR ACCESSORIES | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 8/19/2009 | 74DQXWIRE, GUIDE, CATHETER | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 8/19/2009 | 78KNTTUBES, GASTROINTESTINAL (AND ACCESSORIES) | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 8/19/2009 | 78FBKNEEDLE, ENDOSCOPIC | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 8/19/2009 | 78FHACLAMP, PENILE | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 8/19/2009 | 78EZNDILATOR, CATHETER, URETERAL | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 8/19/2009 | 78KOEDILATOR, URETHRAL | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 8/19/2009 | 78KODCATHETER, UROLOGICAL | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 8/19/2009 | 78KOBCATHETER, SUPRAPUBIC (AND ACCESSORIES) | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 8/19/2009 | 78EYBCATHETER, URETERAL, GASTRO-UROLOGY | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 8/19/2009 | 78LJECATHETER, NEPHROSTOMY | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 8/19/2009 | 78FGESTENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 8/19/2009 | 78FADSTENT, URETERAL | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Ms Surgimedk Healthcare's FDA import refusal history?
Ms Surgimedk Healthcare (FEI: 3007632112) has 15 FDA import refusal record(s) in our database, spanning from 8/19/2009 to 8/19/2009.
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. Ms Surgimedk Healthcare's FEI number is 3007632112.
What types of violations has Ms Surgimedk Healthcare received?
Ms Surgimedk Healthcare 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 Ms Surgimedk Healthcare come from?
All FDA import refusal data for Ms Surgimedk Healthcare 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.