Ningbo Wanrui Medical Instrument
⚠️ Moderate Risk
FEI: 3011847832 • Ningo Zhejiang • CHINA
FEI Number
3011847832
Location
Ningo Zhejiang
Country
CHINAAddress
410 8 Shiqi St, , Ningo Zhejiang, , China
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
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(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
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 Ningbo Wanrui Medical Instrument's FDA import refusal history?
Ningbo Wanrui Medical Instrument (FEI: 3011847832) has 1 FDA import refusal record(s) in our database, spanning from 12/18/2015 to 12/18/2015.
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. Ningbo Wanrui Medical Instrument's FEI number is 3011847832.
What types of violations has Ningbo Wanrui Medical Instrument received?
Ningbo Wanrui Medical Instrument 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 Ningbo Wanrui Medical Instrument come from?
All FDA import refusal data for Ningbo Wanrui Medical Instrument 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.