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Guangzhou RuiKD Photoelectric Technology Co., Ltd.

✅ Low Risk

FEI: 3010993264 • Guangzhou, Baiyun District • CHINA

FEI

FEI Number

3010993264

📍

Location

Guangzhou, Baiyun District

🇨🇳

Country

CHINA
🏢

Address

4th Floor of No. 6 Fenghe Main Street, Renhe Town, Guangzhou, Baiyun District, 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
10/10/2014
Latest Refusal
10/10/2014
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
10/10/2014
79OUHSKIN RESURFACING RF APPLICATOR
118NOT LISTED
San Francisco District Office (SAN-DO)

Frequently Asked Questions

What is Guangzhou RuiKD Photoelectric Technology Co., Ltd.'s FDA import refusal history?

Guangzhou RuiKD Photoelectric Technology Co., Ltd. (FEI: 3010993264) has 1 FDA import refusal record(s) in our database, spanning from 10/10/2014 to 10/10/2014.

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. Guangzhou RuiKD Photoelectric Technology Co., Ltd.'s FEI number is 3010993264.

What types of violations has Guangzhou RuiKD Photoelectric Technology Co., Ltd. received?

Guangzhou RuiKD Photoelectric 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 Guangzhou RuiKD Photoelectric Technology Co., Ltd. come from?

All FDA import refusal data for Guangzhou RuiKD Photoelectric 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.