Shenzhen Mindray Biomedical
⚠️ Moderate Risk
FEI: 3003576550 • China • CHINA
FEI Number
3003576550
Location
China
Country
CHINAAddress
Newport Ctr Phase 2 1-3 3flr, , Tokwawan, China, , 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 PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
Refusal History
Frequently Asked Questions
What is Shenzhen Mindray Biomedical's FDA import refusal history?
Shenzhen Mindray Biomedical (FEI: 3003576550) has 2 FDA import refusal record(s) in our database, spanning from 5/3/2002 to 8/21/2002.
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 Mindray Biomedical's FEI number is 3003576550.
What types of violations has Shenzhen Mindray Biomedical received?
Shenzhen Mindray Biomedical 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 Mindray Biomedical come from?
All FDA import refusal data for Shenzhen Mindray Biomedical 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.