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Shenzhen Well D Medical Electron

⚠️ Moderate Risk

FEI: 3006565394 • Shenzhen • CHINA

FEI

FEI Number

3006565394

📍

Location

Shenzhen

🇨🇳

Country

CHINA
🏢

Address

13 12f Block N New Neergy Bldg, , Shenzhen, , China

Moderate Risk

FDA Import Risk Assessment

28.3
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

1
Total Refusals
1
Unique Violations
9/2/2010
Latest Refusal
9/2/2010
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
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

4761×

NO REGISTR

The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).

Refusal History

DateProductViolationsDivision
9/2/2010
90IYNSYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC
476NO REGISTR
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Shenzhen Well D Medical Electron's FDA import refusal history?

Shenzhen Well D Medical Electron (FEI: 3006565394) has 1 FDA import refusal record(s) in our database, spanning from 9/2/2010 to 9/2/2010.

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. Shenzhen Well D Medical Electron's FEI number is 3006565394.

What types of violations has Shenzhen Well D Medical Electron received?

Shenzhen Well D Medical Electron 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 Shenzhen Well D Medical Electron come from?

All FDA import refusal data for Shenzhen Well D Medical Electron 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.