Foshan Yunsheng Medical Instrument Company Limited
✅ Low Risk
FEI: 3008485457 • Foshan, Guangdong • CHINA
FEI Number
3008485457
Location
Foshan, Guangdong
Country
CHINAAddress
Room 706, NO 43 Jihualu; Shancheng, Foshan, 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
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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(o) in that it is being imported or offered for import into the United States, and the importer, owner, or consignee of such article did not, at the time of offering the article for import, submit to the Secretary a statement that identifies the registration under section 510(i) of the Act of each establishment that with respect to such article is required under such section to register with the Secretary.
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 Foshan Yunsheng Medical Instrument Company Limited's FDA import refusal history?
Foshan Yunsheng Medical Instrument Company Limited (FEI: 3008485457) has 1 FDA import refusal record(s) in our database, spanning from 12/5/2013 to 12/5/2013.
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. Foshan Yunsheng Medical Instrument Company Limited's FEI number is 3008485457.
What types of violations has Foshan Yunsheng Medical Instrument Company Limited received?
Foshan Yunsheng Medical Instrument Company Limited 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 Foshan Yunsheng Medical Instrument Company Limited come from?
All FDA import refusal data for Foshan Yunsheng Medical Instrument Company Limited 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.