Hebei Yuanrun Medical Devices Co., Ltd.
⚠️ Moderate Risk
FEI: 3016245348 • Shijiazhuang, Hebei • CHINA
FEI Number
3016245348
Location
Shijiazhuang, Hebei
Country
CHINAAddress
Lijiazhuang Village, Xin'An Town, Shijiazhuang, Hebei, 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
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
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
Frequently Asked Questions
What is Hebei Yuanrun Medical Devices Co., Ltd.'s FDA import refusal history?
Hebei Yuanrun Medical Devices Co., Ltd. (FEI: 3016245348) has 2 FDA import refusal record(s) in our database, spanning from 3/17/2025 to 3/17/2025.
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. Hebei Yuanrun Medical Devices Co., Ltd.'s FEI number is 3016245348.
What types of violations has Hebei Yuanrun Medical Devices Co., Ltd. received?
Hebei Yuanrun Medical Devices 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 Hebei Yuanrun Medical Devices Co., Ltd. come from?
All FDA import refusal data for Hebei Yuanrun Medical Devices 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.