Jian Yuan Medical Technology Co., Ltd.
⚠️ Moderate Risk
FEI: 3010151271 • Changsha • CHINA
FEI Number
3010151271
Location
Changsha
Country
CHINAAddress
No. 27, Wenxuan Road, High Tech, , Changsha, , China
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
Frequently Asked Questions
What is Jian Yuan Medical Technology Co., Ltd.'s FDA import refusal history?
Jian Yuan Medical Technology Co., Ltd. (FEI: 3010151271) has 2 FDA import refusal record(s) in our database, spanning from 7/29/2013 to 7/29/2013.
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. Jian Yuan Medical Technology Co., Ltd.'s FEI number is 3010151271.
What types of violations has Jian Yuan Medical Technology Co., Ltd. received?
Jian Yuan Medical 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 Jian Yuan Medical Technology Co., Ltd. come from?
All FDA import refusal data for Jian Yuan Medical 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.