QINGDAO MEDICONEX ENTERPRISE CO., LTD.
✅ Low Risk
FEI: 3008731930 • Qingdao, Shandong • CHINA
FEI Number
3008731930
Location
Qingdao, Shandong
Country
CHINAAddress
#Shenghe Bldg. No.58 Room 803,2, Shandongtou Road; Laoshan, Qingdao, Shandong, 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).
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 REGISTR
The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).
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 QINGDAO MEDICONEX ENTERPRISE CO., LTD.'s FDA import refusal history?
QINGDAO MEDICONEX ENTERPRISE CO., LTD. (FEI: 3008731930) has 1 FDA import refusal record(s) in our database, spanning from 5/11/2013 to 5/11/2013.
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. QINGDAO MEDICONEX ENTERPRISE CO., LTD.'s FEI number is 3008731930.
What types of violations has QINGDAO MEDICONEX ENTERPRISE CO., LTD. received?
QINGDAO MEDICONEX ENTERPRISE CO., LTD. has been cited for 5 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 QINGDAO MEDICONEX ENTERPRISE CO., LTD. come from?
All FDA import refusal data for QINGDAO MEDICONEX ENTERPRISE 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.