ImportRefusal LogoImportRefusal

Dragon Heart Medical Devices Co., Ltd.

✅ Low Risk

FEI: 3004215921 • Kaiping, Guangdong • CHINA

FEI

FEI Number

3004215921

📍

Location

Kaiping, Guangdong

🇨🇳

Country

CHINA
🏢

Address

38 Wujin Road, Baihe Town, Kaiping, Guangdong, China

Low Risk

FDA Import Risk Assessment

21.7
LowModerateHighCritical

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

Statistics

3
Total Refusals
1
Unique Violations
8/27/2005
Latest Refusal
8/27/2005
Earliest Refusal

Score Breakdown

Violation Severity
30.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
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

3413×

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
8/27/2005
80LDQDEVICE, GENERAL MEDICAL
341REGISTERED
Los Angeles District Office (LOS-DO)
8/27/2005
80LDQDEVICE, GENERAL MEDICAL
341REGISTERED
Los Angeles District Office (LOS-DO)
8/27/2005
80LDQDEVICE, GENERAL MEDICAL
341REGISTERED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Dragon Heart Medical Devices Co., Ltd.'s FDA import refusal history?

Dragon Heart Medical Devices Co., Ltd. (FEI: 3004215921) has 3 FDA import refusal record(s) in our database, spanning from 8/27/2005 to 8/27/2005.

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. Dragon Heart Medical Devices Co., Ltd.'s FEI number is 3004215921.

What types of violations has Dragon Heart Medical Devices Co., Ltd. received?

Dragon Heart Medical Devices 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 Dragon Heart Medical Devices Co., Ltd. come from?

All FDA import refusal data for Dragon Heart Medical Devices 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.