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Jiangsu Dynamic Medical Technology Co., Ltd.

Low Risk

FEI: 3009598746 • Suzhou, Jiangsu • CHINA

FEI

FEI Number

3009598746

📍

Location

Suzhou, Jiangsu

🇨🇳

Country

CHINA
🏢

Address

No. 108 Xingpu Road, Kunshan, Suzhou, Jiangsu, 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
9/11/2020
Latest Refusal
9/11/2020
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
9/11/2020
73DWMAPPARATUS, SUCTION, PATIENT CARE
118NOT LISTED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Jiangsu Dynamic Medical Technology Co., Ltd.'s FDA import refusal history?

Jiangsu Dynamic Medical Technology Co., Ltd. (FEI: 3009598746) has 1 FDA import refusal record(s) in our database, spanning from 9/11/2020 to 9/11/2020.

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. Jiangsu Dynamic Medical Technology Co., Ltd.'s FEI number is 3009598746.

What types of violations has Jiangsu Dynamic Medical Technology Co., Ltd. received?

Jiangsu Dynamic Medical 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 Jiangsu Dynamic Medical Technology Co., Ltd. come from?

All FDA import refusal data for Jiangsu Dynamic Medical 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.