Yercon Diagnostic Co Ltd
⚠️ Moderate Risk
FEI: 3007908116 • Changchun, Jilin • CHINA
FEI Number
3007908116
Location
Changchun, Jilin
Country
CHINAAddress
2058 Pu East Rd, , Changchun, Jilin, 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
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).
NONSTEEL
Labeling appears false or misleading or fails to bear adequate directions for use,because the article appears to be misrepresented as a disposable single use instrument when it is intended for use as a stainless steel multi-use instrument.
Refusal History
Frequently Asked Questions
What is Yercon Diagnostic Co Ltd's FDA import refusal history?
Yercon Diagnostic Co Ltd (FEI: 3007908116) has 2 FDA import refusal record(s) in our database, spanning from 3/17/2010 to 11/2/2012.
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. Yercon Diagnostic Co Ltd's FEI number is 3007908116.
What types of violations has Yercon Diagnostic Co Ltd received?
Yercon Diagnostic 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 Yercon Diagnostic Co Ltd come from?
All FDA import refusal data for Yercon Diagnostic 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.