Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
⚠️ Moderate Risk
FEI: 3007222337 • Shenzhen, Guangdong • CHINA
FEI Number
3007222337
Location
Shenzhen, Guangdong
Country
CHINAAddress
Baimang, Xili, Buildings 9-13, Baiwangxin High-Tech Ind, Shenzhen, 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
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 |
|---|---|---|---|
| 7/21/2015 | 73BZOSET, TUBING AND SUPPORT, VENTILATOR (W HARNESS) | 508NO 510(K) | San Juan District Office (SJN-DO) |
| 5/1/2014 | 74NPNDEFIBRILLATOR, AUTOMATIC, EXTERNAL, FOR OUT-OF-HOSPITAL USE | Florida District Office (FLA-DO) | |
| 5/1/2014 | 74DRTMONITOR, CARDIAC (INCL. CARDIOTACHOMETER & RATE ALARM) | Florida District Office (FLA-DO) | |
| 2/11/2014 | 79GDGHOOK, SURGICAL, GENERAL & PLASTIC SURGERY | Division of Southeast Imports (DSEI) | |
| 2/11/2014 | 73ONZCONTINUOUS VENTILATOR | Division of Southeast Imports (DSEI) | |
| 2/11/2014 | 73BSZGAS MACHINE, ANESTHESIA | Division of Southeast Imports (DSEI) | |
| 2/11/2014 | 74DPSELECTROCARDIOGRAPH | Division of Southeast Imports (DSEI) | |
| 2/11/2014 | 74MKJAUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) | Division of Southeast Imports (DSEI) | |
| 2/11/2014 | 74MHXMONITOR, PHYSIOLOGICAL, PATIENT | Division of Southeast Imports (DSEI) | |
| 11/13/2002 | 90IWEMONITOR, PATIENT POSITION, LIGHT-BEAM | Seattle District Office (SEA-DO) |
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: 3007222337) has 10 FDA import refusal record(s) in our database, spanning from 11/13/2002 to 7/21/2015.
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. Shenzhen Mindray Bio-Medical Electronics Co., Ltd.'s FEI number is 3007222337.
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.