JINHUA YIDI MEDICAL APPLIANCE
✅ Low Risk
FEI: 3015894931 • Zhejiang • CHINA
FEI Number
3015894931
Location
Zhejiang
Country
CHINAAddress
Zhuama Industrial Park, , Zhejiang, , 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).
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 JINHUA YIDI MEDICAL APPLIANCE's FDA import refusal history?
JINHUA YIDI MEDICAL APPLIANCE (FEI: 3015894931) has 2 FDA import refusal record(s) in our database, spanning from 11/16/2019 to 10/25/2021.
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. JINHUA YIDI MEDICAL APPLIANCE's FEI number is 3015894931.
What types of violations has JINHUA YIDI MEDICAL APPLIANCE received?
JINHUA YIDI MEDICAL APPLIANCE has been cited for 3 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 JINHUA YIDI MEDICAL APPLIANCE come from?
All FDA import refusal data for JINHUA YIDI MEDICAL APPLIANCE 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.