FDA Registration Active 🇨🇳 China

Consona N7S, Consona VI, Consona VT, Consona N7 Exp, Consona N7 Elite, Consona N7T Diagnostic Ultrasound System

Reg #: 3007603826 · FEI: 3007603826 · Expires 2025
Products
3
Proprietary Names
6
Establishment Types
2
Classifications
3

Registration Details

Registration Name
Shenzhen Mindray Bio-Medical Electronics Co.,LTD
Registration Number
3007603826
FEI Number
3007603826
Status
Active
Expiry Year
2025
Initial Importer
No
Address
MINDRAY BUILDING,KEJI 12TH ROAD SOUTH, HI-TECH INDUSTRIAL PARK,NANSHAN
City
SHENZHEN Guangdong
Country
CN

Regulatory Submissions

510(k) Number
K221300

Owner / Operator

Firm Name
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
Operator Number
9058402
Address
MINDRAY BUILDING,KEJI 12TH RD., SOUTH, HI-TECH INDUSTRIAL PARK
City
NANSHAN, SHENZHEN, GUANGDONG
State
CN-GD
Postal Code
518057
Country
CN
Correspondent
Xinbing Wang

US Agent

Business Name
Mindray DS USA, Inc
Contact Name
James Clifford
Address
800 MacArthur Blvd
City
Mahwah
State
NJ
ZIP
07430
Country
US
Phone
201 6709353

Products

Device Name Product Code
System, Imaging, Pulsed Echo, Ultrasonic IYO
Transducer, Ultrasonic, Diagnostic ITX
System, Imaging, Pulsed Doppler, Ultrasonic IYN

Proprietary Names

Consona N7S, Consona VI, Consona VT, Consona N7 Exp, Consona N7 Elite, Consona N7T Diagnostic Ultrasound System Consona NI, Consona NT, Nuewa N9, Recho N9, Consona N9 Exp, Consona N9 Elite Diagnostic Ultrasound System Consona OR, Consona N8S, Consona OI, Consona OT, Consona N8 Exp, Consona N8 Elite Diagnostic Ultrasound System Consona N8T, Consona N7, Consona N7 Pro, Consona N7 Super, Consona VR Diagnostic Ultrasound System Consona N9, Consona N9 Pro, Consona N9 Super, Consona Nova, Consona N9S Diagnostic Ultrasound System Resona N9, Consona N9T, Consona N8, Consona N8 Pro, Consona N8 Super Diagnostic Ultrasound System

Establishment Types

Export Device to the United States But Perform No Other Operation on Device Develop Specifications But Do Not Manufacture At This Facility