Meridian Co., Ltd.
✅ Low Risk
FEI: 3003522440 • Anyang-Si, Gyeonggi-Do • SOUTH KOREA
FEI Number
3003522440
Location
Anyang-Si, Gyeonggi-Do
Country
SOUTH KOREAAddress
4F 196-35, Anyang-Dong, Manan-Gu, , Anyang-Si, Gyeonggi-Do, South Korea
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity violations.
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
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/18/2002 | 84GZODEVICE, GALVANIC SKIN RESPONSE MEASUREMENT | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 1/31/2002 | 84GZODEVICE, GALVANIC SKIN RESPONSE MEASUREMENT | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 1/31/2002 | 84GZODEVICE, GALVANIC SKIN RESPONSE MEASUREMENT | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 1/31/2002 | 84GZODEVICE, GALVANIC SKIN RESPONSE MEASUREMENT | 341REGISTERED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Meridian Co., Ltd.'s FDA import refusal history?
Meridian Co., Ltd. (FEI: 3003522440) has 4 FDA import refusal record(s) in our database, spanning from 1/31/2002 to 3/18/2002.
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. Meridian Co., Ltd.'s FEI number is 3003522440.
What types of violations has Meridian Co., Ltd. received?
Meridian 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 Meridian Co., Ltd. come from?
All FDA import refusal data for Meridian 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.