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SHENZHEN MONDIAL TECHNOLOGY CO., LTD.

✅ Low Risk

FEI: 3008770708 • Shenzhen, Guangdong • CHINA

FEI

FEI Number

3008770708

📍

Location

Shenzhen, Guangdong

🇨🇳

Country

CHINA
🏢

Address

B, NO. 3 Pinghujiedaoban Egong Ling Juwei, Shenzhen, Guangdong, China

Low Risk

FDA Import Risk Assessment

17.5
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
1/4/2022
Latest Refusal
1/4/2022
Earliest Refusal

Score Breakdown

Violation Severity
30.0×40%
Refusal Volume
11.2×30%
Recency
5.6×20%
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

3411×

REGISTERED

It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).

Refusal History

DateProductViolationsDivision
1/4/2022
89ISAMASSAGER, THERAPEUTIC, ELECTRIC
341REGISTERED
Division of West Coast Imports (DWCI)

Frequently Asked Questions

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

SHENZHEN MONDIAL TECHNOLOGY CO., LTD. (FEI: 3008770708) has 1 FDA import refusal record(s) in our database, spanning from 1/4/2022 to 1/4/2022.

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 MONDIAL TECHNOLOGY CO., LTD.'s FEI number is 3008770708.

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

SHENZHEN MONDIAL 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 MONDIAL TECHNOLOGY CO., LTD. come from?

All FDA import refusal data for SHENZHEN MONDIAL 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.