Nuo Yu Rechargeable Battery Inc
✅ Low Risk
FEI: 3010157336 • Baoan • CHINA
FEI Number
3010157336
Location
Baoan
Country
CHINAAddress
12 Hong Xing Bldg Huai De Cui Gang W Rd, , Baoan, , 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).
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).
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
Refusal History
Frequently Asked Questions
What is Nuo Yu Rechargeable Battery Inc's FDA import refusal history?
Nuo Yu Rechargeable Battery Inc (FEI: 3010157336) has 1 FDA import refusal record(s) in our database, spanning from 5/20/2013 to 5/20/2013.
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. Nuo Yu Rechargeable Battery Inc's FEI number is 3010157336.
What types of violations has Nuo Yu Rechargeable Battery Inc received?
Nuo Yu Rechargeable Battery Inc 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 Nuo Yu Rechargeable Battery Inc come from?
All FDA import refusal data for Nuo Yu Rechargeable Battery Inc 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.