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Da Yang Guo Ji Huo Yunj Dai Li Gong

✅ Low Risk

FEI: 3012304904 • Shenzhen • HONG KONG

FEI

FEI Number

3012304904

📍

Location

Shenzhen

🇭🇰

Country

HONG KONG
🏢

Address

103 B7 Ming Kang Garden, Mingzhi Street, , Shenzhen, , Hong Kong

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
6/27/2016
Latest Refusal
6/27/2016
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
6/27/2016
74DXNSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
341REGISTERED
New York District Office (NYK-DO)

Frequently Asked Questions

What is Da Yang Guo Ji Huo Yunj Dai Li Gong's FDA import refusal history?

Da Yang Guo Ji Huo Yunj Dai Li Gong (FEI: 3012304904) has 1 FDA import refusal record(s) in our database, spanning from 6/27/2016 to 6/27/2016.

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. Da Yang Guo Ji Huo Yunj Dai Li Gong's FEI number is 3012304904.

What types of violations has Da Yang Guo Ji Huo Yunj Dai Li Gong received?

Da Yang Guo Ji Huo Yunj Dai Li Gong 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 Da Yang Guo Ji Huo Yunj Dai Li Gong come from?

All FDA import refusal data for Da Yang Guo Ji Huo Yunj Dai Li Gong 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.