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HUBEI GUARDDENT MEDICAL TECHNOLOGY CO., LTD

⚠️ Moderate Risk

FEI: 3018679261 • Wuhan, Hubei • CHINA

FEI

FEI Number

3018679261

📍

Location

Wuhan, Hubei

🇨🇳

Country

CHINA
🏢

Address

Building 2 Room 2 F/15, 139 Hanyang Avenue; Hanyang, Wuhan, Hubei, China

Moderate Risk

FDA Import Risk Assessment

35.6
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
11/15/2023
Latest Refusal
11/15/2023
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
11.2×30%
Recency
56.4×20%
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
11/15/2023
80MMPCOVER, BARRIER, PROTECTIVE
118NOT LISTED
Division of Northeast Imports (DNEI)

Frequently Asked Questions

What is HUBEI GUARDDENT MEDICAL TECHNOLOGY CO., LTD's FDA import refusal history?

HUBEI GUARDDENT MEDICAL TECHNOLOGY CO., LTD (FEI: 3018679261) has 1 FDA import refusal record(s) in our database, spanning from 11/15/2023 to 11/15/2023.

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. HUBEI GUARDDENT MEDICAL TECHNOLOGY CO., LTD's FEI number is 3018679261.

What types of violations has HUBEI GUARDDENT MEDICAL TECHNOLOGY CO., LTD received?

HUBEI GUARDDENT MEDICAL TECHNOLOGY 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 HUBEI GUARDDENT MEDICAL TECHNOLOGY CO., LTD come from?

All FDA import refusal data for HUBEI GUARDDENT MEDICAL TECHNOLOGY 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.