SEJOY BIOMEDICAL
⚠️ Moderate Risk
FEI: 3027888176 • Hangzhou City • CHINA
FEI Number
3027888176
Location
Hangzhou City
Country
CHINAAddress
Area C Bldg, 2 No 365 Wu, Hangzhou City, , 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 SEJOY BIOMEDICAL's FDA import refusal history?
SEJOY BIOMEDICAL (FEI: 3027888176) has 2 FDA import refusal record(s) in our database, spanning from 3/26/2025 to 3/26/2025.
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. SEJOY BIOMEDICAL's FEI number is 3027888176.
What types of violations has SEJOY BIOMEDICAL received?
SEJOY BIOMEDICAL 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 SEJOY BIOMEDICAL come from?
All FDA import refusal data for SEJOY BIOMEDICAL 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.