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Rayence Co. Ltd.

✅ Low Risk

FEI: 3009048384 • Hwaseong, Gyeonggi • SOUTH KOREA

FEI

FEI Number

3009048384

📍

Location

Hwaseong, Gyeonggi

🇰🇷
🏢

Address

14 Samseong1ro1-Gil, , Hwaseong, Gyeonggi, South Korea

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
2
Unique Violations
5/20/2021
Latest Refusal
5/20/2021
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

24801×

RXPERSONAL

The article appears to be a device which requires a prescription from your doctor.

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
5/20/2021
90MUHSYSTEM, X-RAY, EXTRAORAL SOURCE, DIGITAL
2480RXPERSONAL
341REGISTERED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Rayence Co. Ltd.'s FDA import refusal history?

Rayence Co. Ltd. (FEI: 3009048384) has 1 FDA import refusal record(s) in our database, spanning from 5/20/2021 to 5/20/2021.

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. Rayence Co. Ltd.'s FEI number is 3009048384.

What types of violations has Rayence Co. Ltd. received?

Rayence Co. Ltd. has been cited for 2 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 Rayence Co. Ltd. come from?

All FDA import refusal data for Rayence 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.