Foshan Duoyimei Medical Instrument Co., Ltd
✅ Low Risk
FEI: 3009145313 • Foshan City, Guangdong Province • CHINA
FEI Number
3009145313
Location
Foshan City, Guangdong Province
Country
CHINAAddress
No. 6 Keda South Road, Shishan, Industrial Park A, Nanhai District, Foshan City, Guangdong Province, 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).
Refusal History
Frequently Asked Questions
What is Foshan Duoyimei Medical Instrument Co., Ltd's FDA import refusal history?
Foshan Duoyimei Medical Instrument Co., Ltd (FEI: 3009145313) has 1 FDA import refusal record(s) in our database, spanning from 10/21/2011 to 10/21/2011.
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 Duoyimei Medical Instrument Co., Ltd's FEI number is 3009145313.
What types of violations has Foshan Duoyimei Medical Instrument Co., Ltd received?
Foshan Duoyimei Medical Instrument 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 Foshan Duoyimei Medical Instrument Co., Ltd come from?
All FDA import refusal data for Foshan Duoyimei Medical Instrument 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.