Saeik Medical Co., Ltd.
⚠️ Moderate Risk
FEI: 3003834153 • Bucheon City, Gyeonggi-Do • SOUTH KOREA
FEI Number
3003834153
Location
Bucheon City, Gyeonggi-Do
Country
SOUTH KOREAAddress
156-8, Chuneui-Dong, Wonmi-Ku, Wonmi-Ku, Bucheon City, Gyeonggi-Do, South Korea
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
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
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/18/2011 | 84HCCDEVICE, BIOFEEDBACK | 237NO PMA | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is Saeik Medical Co., Ltd.'s FDA import refusal history?
Saeik Medical Co., Ltd. (FEI: 3003834153) has 1 FDA import refusal record(s) in our database, spanning from 7/18/2011 to 7/18/2011.
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. Saeik Medical Co., Ltd.'s FEI number is 3003834153.
What types of violations has Saeik Medical Co., Ltd. received?
Saeik Medical 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 Saeik Medical Co., Ltd. come from?
All FDA import refusal data for Saeik Medical 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.