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JIANGSU WEIKANG JIEJING MEDICAL APPARATUS CO., LTD.

✅ Low Risk

FEI: 3010594263 • Shuyang, Jiangsu • CHINA

FEI

FEI Number

3010594263

📍

Location

Shuyang, Jiangsu

🇨🇳

Country

CHINA
🏢

Address

# 18 Wenzhou Road, Economical Development District, Shuyang, 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
7/19/2018
Latest Refusal
7/19/2018
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
7/19/2018
73KGBMASK, OXYGEN, NON-REBREATHING
341REGISTERED
Division of West Coast Imports (DWCI)

Frequently Asked Questions

What is JIANGSU WEIKANG JIEJING MEDICAL APPARATUS CO., LTD.'s FDA import refusal history?

JIANGSU WEIKANG JIEJING MEDICAL APPARATUS CO., LTD. (FEI: 3010594263) has 1 FDA import refusal record(s) in our database, spanning from 7/19/2018 to 7/19/2018.

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 WEIKANG JIEJING MEDICAL APPARATUS CO., LTD.'s FEI number is 3010594263.

What types of violations has JIANGSU WEIKANG JIEJING MEDICAL APPARATUS CO., LTD. received?

JIANGSU WEIKANG JIEJING MEDICAL APPARATUS 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 WEIKANG JIEJING MEDICAL APPARATUS CO., LTD. come from?

All FDA import refusal data for JIANGSU WEIKANG JIEJING MEDICAL APPARATUS 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.