Sono Scape Co Ltd
✅ Low Risk
FEI: 3006422837 • Shenzhen, Guangdong • CHINA
FEI Number
3006422837
Location
Shenzhen, Guangdong
Country
CHINAAddress
Yizhe Building F/9, Zhongshanyuanlu, Shenzhen, Guangdong, 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
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
NO TAG
The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product to which is not affixed a certification in the form of a label or tag in conformity with section 534(h).
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 Sono Scape Co Ltd's FDA import refusal history?
Sono Scape Co Ltd (FEI: 3006422837) has 2 FDA import refusal record(s) in our database, spanning from 10/25/2007 to 1/3/2008.
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. Sono Scape Co Ltd's FEI number is 3006422837.
What types of violations has Sono Scape Co Ltd received?
Sono Scape Co Ltd 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 Sono Scape Co Ltd come from?
All FDA import refusal data for Sono Scape 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.