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WUXI XINDA MEDICAL DEVICE CO., LTD.

✅ Low Risk

FEI: 3003342975 • Wuxi • CHINA

FEI

FEI Number

3003342975

📍

Location

Wuxi

🇨🇳

Country

CHINA
🏢

Address

NO 42 Xixin Road, Xibei Town, Xishan District, Wuxi, , 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
11/9/2001
Latest Refusal
11/9/2001
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
11/9/2001
79FMKSINGLE USE ONLY BLOOD LANCET WITH AN INTEGRAL SHARPS INJURY PREVENTION FEATURE
341REGISTERED
Florida District Office (FLA-DO)

Frequently Asked Questions

What is WUXI XINDA MEDICAL DEVICE CO., LTD.'s FDA import refusal history?

WUXI XINDA MEDICAL DEVICE CO., LTD. (FEI: 3003342975) has 1 FDA import refusal record(s) in our database, spanning from 11/9/2001 to 11/9/2001.

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. WUXI XINDA MEDICAL DEVICE CO., LTD.'s FEI number is 3003342975.

What types of violations has WUXI XINDA MEDICAL DEVICE CO., LTD. received?

WUXI XINDA MEDICAL DEVICE 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 WUXI XINDA MEDICAL DEVICE CO., LTD. come from?

All FDA import refusal data for WUXI XINDA MEDICAL DEVICE 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.