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Zhangjiagang Emergency Medical Service Technology Co., Ltd.

⚠️ Moderate Risk

FEI: 3009298413 • Zhangjiagang, Jiangsu • CHINA

FEI

FEI Number

3009298413

📍

Location

Zhangjiagang, Jiangsu

🇨🇳

Country

CHINA
🏢

Address

Chenlong Building 8320, Yangshe Town, Zhangjiagang, Jiangsu, China

Moderate Risk

FDA Import Risk Assessment

25.2
LowModerateHighCritical

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

Statistics

3
Total Refusals
2
Unique Violations
10/9/2014
Latest Refusal
3/29/2012
Earliest Refusal

Score Breakdown

Violation Severity
43.3×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
11.8×10%
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).

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
10/9/2014
73LYMDEVICE, CPR ASSIST
118NOT LISTED
Division of Southeast Imports (DSEI)
7/11/2012
80NZDSTRETCHER, PATIENT RESTRAINT
118NOT LISTED
New York District Office (NYK-DO)
3/29/2012
87HSTAPPARATUS, TRACTION, NON-POWERED
341REGISTERED
Division of Northeast Imports (DNEI)

Frequently Asked Questions

What is Zhangjiagang Emergency Medical Service Technology Co., Ltd.'s FDA import refusal history?

Zhangjiagang Emergency Medical Service Technology Co., Ltd. (FEI: 3009298413) has 3 FDA import refusal record(s) in our database, spanning from 3/29/2012 to 10/9/2014.

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. Zhangjiagang Emergency Medical Service Technology Co., Ltd.'s FEI number is 3009298413.

What types of violations has Zhangjiagang Emergency Medical Service Technology Co., Ltd. received?

Zhangjiagang Emergency Medical Service Technology Co., Ltd. has been cited for 2 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 Zhangjiagang Emergency Medical Service Technology Co., Ltd. come from?

All FDA import refusal data for Zhangjiagang Emergency Medical Service 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.