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SHANGHAI XINHUA EGM CO., LTD.

✅ Low Risk

FEI: 3006946384 • Shanghai, Shanghai • CHINA

FEI

FEI Number

3006946384

📍

Location

Shanghai, Shanghai

🇨🇳

Country

CHINA
🏢

Address

6E Wulumuqi Nanlu, , Shanghai, Shanghai, China

Low Risk

FDA Import Risk Assessment

24.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
9/9/2011
Latest Refusal
9/9/2011
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
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

1181×

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
9/9/2011
89ONHPOWERED LASER NON-THEMAL INSTRUMENT WITH NON-HEATING EFFECT FOR ADJUNCTIVE USE IN PATH THERAPY
118NOT LISTED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is SHANGHAI XINHUA EGM CO., LTD.'s FDA import refusal history?

SHANGHAI XINHUA EGM CO., LTD. (FEI: 3006946384) has 1 FDA import refusal record(s) in our database, spanning from 9/9/2011 to 9/9/2011.

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. SHANGHAI XINHUA EGM CO., LTD.'s FEI number is 3006946384.

What types of violations has SHANGHAI XINHUA EGM CO., LTD. received?

SHANGHAI XINHUA EGM 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 SHANGHAI XINHUA EGM CO., LTD. come from?

All FDA import refusal data for SHANGHAI XINHUA EGM 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.