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Edan Intruments Inc

⚠️ Moderate Risk

FEI: 3008308041 • Shenzhen, Guangdong • CHINA

FEI

FEI Number

3008308041

📍

Location

Shenzhen, Guangdong

🇨🇳

Country

CHINA
🏢

Address

1019 Nanhailu, Nanshan, Shenzhen, Guangdong, China

Moderate Risk

FDA Import Risk Assessment

29.7
LowModerateHighCritical

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

Statistics

3
Total Refusals
1
Unique Violations
9/2/2010
Latest Refusal
9/2/2010
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
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

1183×

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

DateProductViolationsDivision
9/2/2010
74MWIMONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS)
118NOT LISTED
Southwest Import District Office (SWI-DO)
9/2/2010
74DQAOXIMETER
118NOT LISTED
Southwest Import District Office (SWI-DO)
9/2/2010
74DXQCUFF, BLOOD-PRESSURE
118NOT LISTED
Southwest Import District Office (SWI-DO)

Frequently Asked Questions

What is Edan Intruments Inc's FDA import refusal history?

Edan Intruments Inc (FEI: 3008308041) has 3 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. Edan Intruments Inc's FEI number is 3008308041.

What types of violations has Edan Intruments Inc received?

Edan Intruments 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 Edan Intruments Inc come from?

All FDA import refusal data for Edan Intruments 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.