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SHENZHEN ASIA UNIVERSAL TECHNOLOGY CO.,LTD

⚠️ Moderate Risk

FEI: 3030403030 • Shenzhen, Guangdong • CHINA

FEI

FEI Number

3030403030

📍

Location

Shenzhen, Guangdong

🇨🇳

Country

CHINA
🏢

Address

Yishang Centre No. 22 Room 05 Floor 22nd, Jian South Rd; Baoan District, Shenzhen, Guangdong, China

Moderate Risk

FDA Import Risk Assessment

43.7
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
11/21/2025
Latest Refusal
11/21/2025
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
11.2×30%
Recency
96.9×20%
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
11/21/2025
77QUHSELF-FITTING AIR-CONDUCTION HEARING AID, OVER THE COUNTER
118NOT LISTED
Division of Northern Border Imports (DNBI)

Frequently Asked Questions

What is SHENZHEN ASIA UNIVERSAL TECHNOLOGY CO.,LTD's FDA import refusal history?

SHENZHEN ASIA UNIVERSAL TECHNOLOGY CO.,LTD (FEI: 3030403030) has 1 FDA import refusal record(s) in our database, spanning from 11/21/2025 to 11/21/2025.

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 ASIA UNIVERSAL TECHNOLOGY CO.,LTD's FEI number is 3030403030.

What types of violations has SHENZHEN ASIA UNIVERSAL TECHNOLOGY CO.,LTD received?

SHENZHEN ASIA UNIVERSAL TECHNOLOGY 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 SHENZHEN ASIA UNIVERSAL TECHNOLOGY CO.,LTD come from?

All FDA import refusal data for SHENZHEN ASIA UNIVERSAL TECHNOLOGY 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.