Skanray Technologies Pvt. Ltd
⚠️ Moderate Risk
FEI: 3002513440 • Mysore, Karnataka • INDIA
FEI Number
3002513440
Location
Mysore, Karnataka
Country
INDIAAddress
360 Plot No, Hebbal - Hootagalli; Kiadb Ind Area, Mysore, Karnataka, 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
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).
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).
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 |
|---|---|---|---|
| 10/12/2006 | 74MHXMONITOR, PHYSIOLOGICAL, PATIENT | San Francisco District Office (SAN-DO) | |
| 6/6/2006 | 74MSXSYSTEM, NETWORK AND COMMUNICATION, PHYSIOLOGICAL MONITORS | 341REGISTERED | Florida District Office (FLA-DO) |
| 7/11/2005 | 74MSXSYSTEM, NETWORK AND COMMUNICATION, PHYSIOLOGICAL MONITORS | 341REGISTERED | Florida District Office (FLA-DO) |
| 5/6/2005 | 74MSXSYSTEM, NETWORK AND COMMUNICATION, PHYSIOLOGICAL MONITORS | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 4/13/2005 | 74MSXSYSTEM, NETWORK AND COMMUNICATION, PHYSIOLOGICAL MONITORS | 341REGISTERED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Skanray Technologies Pvt. Ltd's FDA import refusal history?
Skanray Technologies Pvt. Ltd (FEI: 3002513440) has 5 FDA import refusal record(s) in our database, spanning from 4/13/2005 to 10/12/2006.
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. Skanray Technologies Pvt. Ltd's FEI number is 3002513440.
What types of violations has Skanray Technologies Pvt. Ltd received?
Skanray Technologies Pvt. Ltd has been cited for 3 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 Skanray Technologies Pvt. Ltd come from?
All FDA import refusal data for Skanray Technologies 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.