SHENZHEN KINGFOCUS BIOMEDICAL ENGINEERING CO, LTD
⚠️ Moderate Risk
FEI: 3017195039 • Shenzhen • CHINA
FEI Number
3017195039
Location
Shenzhen
Country
CHINAAddress
Fl R, 4th 71-5 Xintian Ave, Shenzhen, , 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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/12/2022 | 83QLWCOVID-19 TEST HOME COLLECTION KIT DEVICES | 508NO 510(K) | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is SHENZHEN KINGFOCUS BIOMEDICAL ENGINEERING CO, LTD's FDA import refusal history?
SHENZHEN KINGFOCUS BIOMEDICAL ENGINEERING CO, LTD (FEI: 3017195039) has 1 FDA import refusal record(s) in our database, spanning from 8/12/2022 to 8/12/2022.
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. SHENZHEN KINGFOCUS BIOMEDICAL ENGINEERING CO, LTD's FEI number is 3017195039.
What types of violations has SHENZHEN KINGFOCUS BIOMEDICAL ENGINEERING CO, LTD received?
SHENZHEN KINGFOCUS BIOMEDICAL ENGINEERING CO, LTD has been cited for 1 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 SHENZHEN KINGFOCUS BIOMEDICAL ENGINEERING CO, LTD come from?
All FDA import refusal data for SHENZHEN KINGFOCUS BIOMEDICAL 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.