ImportRefusal LogoImportRefusal

DAESUNGMEDICAL CO., LTD.

✅ Low Risk

FEI: 3007124052 • Iksan, Jeonrabuk • SOUTH KOREA

FEI

FEI Number

3007124052

📍

Location

Iksan, Jeonrabuk

🇰🇷
🏢

Address

125-6 Sandangupyeong-Gil, Nangsan-Myeon, Iksan, Jeonrabuk, 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
3/15/2012
Latest Refusal
3/15/2012
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

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).

5081×

NO 510(K)

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.

Refusal History

DateProductViolationsDivision
3/15/2012
80MQXNEEDLE, ACUPUNCTURE, SINGLE USE
341REGISTERED
508NO 510(K)
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is DAESUNGMEDICAL CO., LTD.'s FDA import refusal history?

DAESUNGMEDICAL CO., LTD. (FEI: 3007124052) has 1 FDA import refusal record(s) in our database, spanning from 3/15/2012 to 3/15/2012.

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. DAESUNGMEDICAL CO., LTD.'s FEI number is 3007124052.

What types of violations has DAESUNGMEDICAL CO., LTD. received?

DAESUNGMEDICAL 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 DAESUNGMEDICAL CO., LTD. come from?

All FDA import refusal data for DAESUNGMEDICAL 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.