Ningbo Diaier Electronic Co., Ltd
✅ Low Risk
FEI: 3008113923 • Yuyao • CHINA
FEI Number
3008113923
Location
Yuyao
Country
CHINAAddress
No. 1 Beixing Rd, Mazhu Town Yuyao Zhej, Yuyao, , 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
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
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 Ningbo Diaier Electronic Co., Ltd's FDA import refusal history?
Ningbo Diaier Electronic Co., Ltd (FEI: 3008113923) has 1 FDA import refusal record(s) in our database, spanning from 6/30/2010 to 6/30/2010.
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. Ningbo Diaier Electronic Co., Ltd's FEI number is 3008113923.
What types of violations has Ningbo Diaier Electronic Co., Ltd received?
Ningbo Diaier Electronic 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 Ningbo Diaier Electronic Co., Ltd come from?
All FDA import refusal data for Ningbo Diaier Electronic 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.