Surgimedik Healthcare
⚠️ Moderate Risk
FEI: 3006992278 • Surat, Gujarat • INDIA
FEI Number
3006992278
Location
Surat, Gujarat
Country
INDIAAddress
223 Plot, , Surat, Gujarat, 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
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/11/2012 | 78EYTSHEATH, CORRUGATED RUBBER, FOR NONINDWELLING CATHETER | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 6/11/2012 | 78LJECATHETER, NEPHROSTOMY | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 6/11/2012 | 79HTDFORCEPS | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 6/11/2012 | 78OCYENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 6/11/2012 | 87HWBEXTRACTOR | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 6/11/2012 | 78KOEDILATOR, URETHRAL | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 1/6/2012 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 1/6/2012 | 78FBKNEEDLE, ENDOSCOPIC | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 1/6/2012 | 78GBMCATHETER, URETHRAL | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 1/6/2012 | 78OCYENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 1/6/2012 | 74DYBINTRODUCER, CATHETER | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 1/6/2012 | 78NMXNEEDLE AND NEEDLE SET, GASTRO-UROLOGY, REPROCESSED | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 1/6/2012 | 80LDQDEVICE, GENERAL MEDICAL | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 1/6/2012 | 85NTSDILATOR, CERVICAL, BALLOON | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 1/6/2012 | 78MXQSTENT, URETHRAL, EXTERNAL SPHINCTER, PERMANENT | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 1/6/2012 | 78MXQSTENT, URETHRAL, EXTERNAL SPHINCTER, PERMANENT | 118NOT LISTED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Surgimedik Healthcare's FDA import refusal history?
Surgimedik Healthcare (FEI: 3006992278) has 16 FDA import refusal record(s) in our database, spanning from 1/6/2012 to 6/11/2012.
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. Surgimedik Healthcare's FEI number is 3006992278.
What types of violations has Surgimedik Healthcare received?
Surgimedik 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 Surgimedik Healthcare come from?
All FDA import refusal data for Surgimedik 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.