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Diros Technology, Inc.

✅ Low Risk

FEI: 3003630373 • Markham, Ontario • CANADA

FEI

FEI Number

3003630373

📍

Location

Markham, Ontario

🇨🇦

Country

CANADA
🏢

Address

120 Gibson Dr, , Markham, Ontario, Canada

Low Risk

FDA Import Risk Assessment

20.2
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

4
Total Refusals
1
Unique Violations
6/14/2021
Latest Refusal
12/12/2011
Earliest Refusal

Score Breakdown

Violation Severity
30.0×40%
Refusal Volume
25.9×30%
Recency
0.0×20%
Frequency
4.2×10%
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

3414×

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).

Refusal History

DateProductViolationsDivision
6/14/2021
84GXIPROBE, RADIOFREQUENCY LESION
341REGISTERED
Division of Southeast Imports (DSEI)
12/12/2011
84GXIPROBE, RADIOFREQUENCY LESION
341REGISTERED
Detroit District Office (DET-DO)
12/12/2011
84GXDGENERATOR, LESION, RADIOFREQUENCY
341REGISTERED
Detroit District Office (DET-DO)
12/12/2011
84GXDGENERATOR, LESION, RADIOFREQUENCY
341REGISTERED
Detroit District Office (DET-DO)

Frequently Asked Questions

What is Diros Technology, Inc.'s FDA import refusal history?

Diros Technology, Inc. (FEI: 3003630373) has 4 FDA import refusal record(s) in our database, spanning from 12/12/2011 to 6/14/2021.

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. Diros Technology, Inc.'s FEI number is 3003630373.

What types of violations has Diros Technology, Inc. received?

Diros Technology, 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 Diros Technology, Inc. come from?

All FDA import refusal data for Diros Technology, 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.