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WENZHOU LONGWAN MEDICAL DEVICE FACTORY

✅ Low Risk

FEI: 3006113277 • Wenzhou, Zhejiang • CHINA

FEI

FEI Number

3006113277

📍

Location

Wenzhou, Zhejiang

🇨🇳

Country

CHINA
🏢

Address

Bldg 27 Unit 4, No. 706 Yanyun Road, Oujiangkou Industrial Cluster District, Wenzhou, Zhejiang, China

Low Risk

FDA Import Risk Assessment

24.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
9/30/2018
Latest Refusal
9/30/2018
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
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

1181×

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).

Refusal History

DateProductViolationsDivision
9/30/2018
74KRKMANOMETER, BLOOD-PRESSURE, VENOUS
118NOT LISTED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is WENZHOU LONGWAN MEDICAL DEVICE FACTORY's FDA import refusal history?

WENZHOU LONGWAN MEDICAL DEVICE FACTORY (FEI: 3006113277) has 1 FDA import refusal record(s) in our database, spanning from 9/30/2018 to 9/30/2018.

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. WENZHOU LONGWAN MEDICAL DEVICE FACTORY's FEI number is 3006113277.

What types of violations has WENZHOU LONGWAN MEDICAL DEVICE FACTORY received?

WENZHOU LONGWAN MEDICAL DEVICE FACTORY 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 WENZHOU LONGWAN MEDICAL DEVICE FACTORY come from?

All FDA import refusal data for WENZHOU LONGWAN MEDICAL DEVICE FACTORY 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.