SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.
⚠️ Moderate Risk
FEI: 3007603826 • Shenzhen • CHINA
FEI Number
3007603826
Location
Shenzhen
Country
CHINAAddress
Mindray Bldg., Keji 12th Road South, 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
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).
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.
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 |
|---|---|---|---|
| 7/24/2020 | 81JOXANALYZER, HEPARIN, AUTOMATED | Division of Southeast Imports (DSEI) | |
| 10/4/2011 | 76EJBHANDLE, INSTRUMENT, DENTAL | Division of Southeast Imports (DSEI) | |
| 9/29/2011 | 85HEMIMAGER, ULTRASONIC OBSTETRIC-GYNECOLOGIC | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 7/28/2011 | 90IYOSYSTEM, IMAGING, PULSED ECHO, ULTRASONIC | Division of Southeast Imports (DSEI) | |
| 6/10/2011 | 74MHXMONITOR, PHYSIOLOGICAL, PATIENT | 118NOT LISTED | Florida District Office (FLA-DO) |
| 6/10/2011 | 74DRKDC-DEFIBRILLATOR, HIGH ENERGY, (INCLUDING PADDLES) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 6/10/2011 | 74MHXMONITOR, PHYSIOLOGICAL, PATIENT | 118NOT LISTED | Florida District Office (FLA-DO) |
| 6/10/2011 | 74MHXMONITOR, PHYSIOLOGICAL, PATIENT | 118NOT LISTED | Florida District Office (FLA-DO) |
| 3/19/2009 | 74MLCMONITOR, ST SEGMENT | Division of Southeast Imports (DSEI) | |
| 9/19/2008 | 73LKDMONITOR, CARBON-DIOXIDE, CUTANEOUS | 118NOT LISTED | Florida District Office (FLA-DO) |
| 9/19/2008 | 73LKDMONITOR, CARBON-DIOXIDE, CUTANEOUS | 118NOT LISTED | Florida District Office (FLA-DO) |
| 8/12/2008 | 73LKDMONITOR, CARBON-DIOXIDE, CUTANEOUS | Florida District Office (FLA-DO) | |
| 4/2/2008 | 74MHXMONITOR, PHYSIOLOGICAL, PATIENT | 341REGISTERED | Seattle District Office (SEA-DO) |
| 3/5/2008 | 80LNXCOMPUTERS AND SOFTWARE, MEDICAL | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 10/30/2007 | 74DRTMONITOR, CARDIAC (INCL. CARDIOTACHOMETER & RATE ALARM) | Florida District Office (FLA-DO) | |
| 8/10/2007 | 80KMIMONITOR, BED PATIENT | Division of Southeast Imports (DSEI) | |
| 2/28/2007 | 74DRTMONITOR, CARDIAC (INCL. CARDIOTACHOMETER & RATE ALARM) | Florida District Office (FLA-DO) | |
| 2/14/2007 | 74DRTMONITOR, CARDIAC (INCL. CARDIOTACHOMETER & RATE ALARM) | Florida District Office (FLA-DO) | |
| 9/5/2006 | 73BZNCART, EMERGENCY, CARDIOPULMONARY (EXCLUDING EQUIPMENT) | 341REGISTERED | Florida District Office (FLA-DO) |
| 8/22/2006 | 73BZNCART, EMERGENCY, CARDIOPULMONARY (EXCLUDING EQUIPMENT) | Florida District Office (FLA-DO) | |
| 8/22/2006 | 90ITXTRANSDUCER, ULTRASONIC, DIAGNOSTIC | Florida District Office (FLA-DO) | |
| 8/22/2006 | 90ITXTRANSDUCER, ULTRASONIC, DIAGNOSTIC | Florida District Office (FLA-DO) | |
| 8/22/2006 | 74MWIMONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS) | Florida District Office (FLA-DO) | |
| 8/22/2006 | 74DQAOXIMETER | Florida District Office (FLA-DO) | |
| 8/22/2006 | 74MWIMONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS) | Florida District Office (FLA-DO) | |
| 8/22/2006 | 74DRTMONITOR, CARDIAC (INCL. CARDIOTACHOMETER & RATE ALARM) | Florida District Office (FLA-DO) | |
| 8/22/2006 | 74DRTMONITOR, CARDIAC (INCL. CARDIOTACHOMETER & RATE ALARM) | Florida District Office (FLA-DO) | |
| 9/7/2005 | 85HEKMONITOR, HEART SOUND, FETAL, ULTRASONIC | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.'s FDA import refusal history?
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. (FEI: 3007603826) has 28 FDA import refusal record(s) in our database, spanning from 9/7/2005 to 7/24/2020.
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 BIO-MEDICAL ELECTRONICS CO., LTD.'s FEI number is 3007603826.
What types of violations has SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. received?
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. has been cited for 4 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 BIO-MEDICAL ELECTRONICS CO., LTD. come from?
All FDA import refusal data for SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS 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.