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Suzhou Zede Medical Instrument Co.,

⚠️ Moderate Risk

FEI: 3012240218 • Suzhou, Jiangsu • CHINA

FEI

FEI Number

3012240218

📍

Location

Suzhou, Jiangsu

🇨🇳

Country

CHINA
🏢

Address

4-3-E Xiandai Ind Fang No.333 Xingpu Rd, Pingjiang, Suzhou, Jiangsu, China

Moderate Risk

FDA Import Risk Assessment

32.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
2/16/2021
Latest Refusal
2/16/2021
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
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

161×

DIRECTIONS

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.

Refusal History

DateProductViolationsDivision
2/16/2021
68MHG08INFUSION PUMPS (NONHUMAN)
16DIRECTIONS
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Suzhou Zede Medical Instrument Co.,'s FDA import refusal history?

Suzhou Zede Medical Instrument Co., (FEI: 3012240218) has 1 FDA import refusal record(s) in our database, spanning from 2/16/2021 to 2/16/2021.

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. Suzhou Zede Medical Instrument Co.,'s FEI number is 3012240218.

What types of violations has Suzhou Zede Medical Instrument Co., received?

Suzhou Zede Medical Instrument Co., 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 Suzhou Zede Medical Instrument Co., come from?

All FDA import refusal data for Suzhou Zede Medical Instrument Co., 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.