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JIANGSU RIXIN MEDICAL EQUIPMENT CO., LTD

✅ Low Risk

FEI: 3007662999 • Suzhou, Jiangsu • CHINA

FEI

FEI Number

3007662999

📍

Location

Suzhou, Jiangsu

🇨🇳

Country

CHINA
🏢

Address

No 427 Yangjin Road, Jinfengzhen Zhangjiagang Shi, Suzhou, Jiangsu, China

Low Risk

FDA Import Risk Assessment

16.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
8/15/2013
Latest Refusal
8/15/2013
Earliest Refusal

Score Breakdown

Violation Severity
30.0×40%
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

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
8/15/2013
80FPOSTRETCHER, WHEELED
341REGISTERED
Florida District Office (FLA-DO)

Frequently Asked Questions

What is JIANGSU RIXIN MEDICAL EQUIPMENT CO., LTD's FDA import refusal history?

JIANGSU RIXIN MEDICAL EQUIPMENT CO., LTD (FEI: 3007662999) has 1 FDA import refusal record(s) in our database, spanning from 8/15/2013 to 8/15/2013.

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 RIXIN MEDICAL EQUIPMENT CO., LTD's FEI number is 3007662999.

What types of violations has JIANGSU RIXIN MEDICAL EQUIPMENT CO., LTD received?

JIANGSU RIXIN MEDICAL EQUIPMENT 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 RIXIN MEDICAL EQUIPMENT CO., LTD come from?

All FDA import refusal data for JIANGSU RIXIN MEDICAL EQUIPMENT 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.