Medionics International Inc.
⚠️ Moderate Risk
FEI: 3002807599 • Markham, Ontario • CANADA
FEI Number
3002807599
Location
Markham, Ontario
Country
CANADAAddress
114 Anderson Avenue, , Markham, Ontario, Canada
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 PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/27/2014 | 80FPASET, ADMINISTRATION, INTRAVASCULAR | 237NO PMA | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Medionics International Inc.'s FDA import refusal history?
Medionics International Inc. (FEI: 3002807599) has 1 FDA import refusal record(s) in our database, spanning from 5/27/2014 to 5/27/2014.
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. Medionics International Inc.'s FEI number is 3002807599.
What types of violations has Medionics International Inc. received?
Medionics International Inc. 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 Medionics International Inc. come from?
All FDA import refusal data for Medionics International Inc. 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.