Zhuhai Encode Medical Engineering Co., Ltd
⚠️ Moderate Risk
FEI: 3016656228 • Zhuhai, Guangdong • CHINA
FEI Number
3016656228
Location
Zhuhai, Guangdong
Country
CHINAAddress
No 20 Honghui Road, Xiaolinzhen, Zhuhai, Guangdong, 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
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.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/20/2021 | 83QKPCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 12/18/2020 | 83QKOREAGENT, CORONAVIRUS SEROLOGICAL | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 6/15/2020 | 83QKOREAGENT, CORONAVIRUS SEROLOGICAL | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 8/31/2018 | 91NGLTEST, OPIATES, OVER THE COUNTER | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Zhuhai Encode Medical Engineering Co., Ltd's FDA import refusal history?
Zhuhai Encode Medical Engineering Co., Ltd (FEI: 3016656228) has 4 FDA import refusal record(s) in our database, spanning from 8/31/2018 to 7/20/2021.
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. Zhuhai Encode Medical Engineering Co., Ltd's FEI number is 3016656228.
What types of violations has Zhuhai Encode Medical Engineering Co., Ltd received?
Zhuhai Encode Medical Engineering 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 Zhuhai Encode Medical Engineering Co., Ltd come from?
All FDA import refusal data for Zhuhai Encode Medical Engineering 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.