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Yimei Dental Industry Co Ltd

⚠️ Moderate Risk

FEI: 3007505082 • Zhengzhou, Henan • CHINA

FEI

FEI Number

3007505082

📍

Location

Zhengzhou, Henan

🇨🇳

Country

CHINA
🏢

Address

1st Fl Apt 99, , Zhengzhou, Henan, China

Moderate Risk

FDA Import Risk Assessment

27.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
1
Unique Violations
1/22/2010
Latest Refusal
1/22/2010
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
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

1182×

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
1/22/2010
76ELCSCALER, ULTRASONIC
118NOT LISTED
Southwest Import District Office (SWI-DO)
1/22/2010
76EIAUNIT, OPERATIVE DENTAL
118NOT LISTED
Southwest Import District Office (SWI-DO)

Frequently Asked Questions

What is Yimei Dental Industry Co Ltd's FDA import refusal history?

Yimei Dental Industry Co Ltd (FEI: 3007505082) has 2 FDA import refusal record(s) in our database, spanning from 1/22/2010 to 1/22/2010.

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. Yimei Dental Industry Co Ltd's FEI number is 3007505082.

What types of violations has Yimei Dental Industry Co Ltd received?

Yimei Dental Industry Co Ltd 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 Yimei Dental Industry Co Ltd come from?

All FDA import refusal data for Yimei Dental Industry Co 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.