HEBEI TENGJIAN MEDICAL DEVICE CO
✅ Low Risk
FEI: 3013713824 • Shijiazhuang • CHINA
FEI Number
3013713824
Location
Shijiazhuang
Country
CHINAAddress
No. 2 East Bridge Road, City, He, Shijiazhuang, , China
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
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
Refusal History
Frequently Asked Questions
What is HEBEI TENGJIAN MEDICAL DEVICE CO's FDA import refusal history?
HEBEI TENGJIAN MEDICAL DEVICE CO (FEI: 3013713824) has 1 FDA import refusal record(s) in our database, spanning from 9/15/2017 to 9/15/2017.
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 TENGJIAN MEDICAL DEVICE CO's FEI number is 3013713824.
What types of violations has HEBEI TENGJIAN MEDICAL DEVICE CO received?
HEBEI TENGJIAN MEDICAL DEVICE CO 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 TENGJIAN MEDICAL DEVICE CO come from?
All FDA import refusal data for HEBEI TENGJIAN MEDICAL DEVICE CO 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.