FDA Registration Active 🇨🇳 China

CHISON Medical Technologies Co., Ltd.

Reg #: 3004753388 · FEI: 3004753388 · Expires 2026
Products
5
Proprietary Names
58
Establishment Types
2
Classifications
5

Registration Details

Registration Name
CHISON Medical Technologies Co., Ltd.
Registration Number
3004753388
FEI Number
3004753388
Status
Active
Expiry Year
2026
Initial Importer
No
Address
No.3 Changjiang South Road, Xinwu District, No.9, Xinhuihuan Road, Xinwu District
City
WUXI Jiangsu
Country
CN

Regulatory Submissions

510(k) Number
K201969

Owner / Operator

Firm Name
CHISON Medical Technologies Co., Ltd.
Operator Number
9066279
Address
No.3 Changjiang South Road, Xinwu District, No.9, Xinhuihuan Road, Xinwu District
City
Wuxi
State
Jiangsu
Postal Code
214028
Country
CN
Correspondent
RUOLI - MO

US Agent

Business Name
MID-LINK INTERNATIONAL CO., LTD
Contact Name
Marco Mu
Address
2219 Rimlang Drive, Suite 301
City
Bellingham
State
WA
ZIP
98226
Country
US
Phone
702 2095185

Products

Device Name Product Code
System, Imaging, Pulsed Echo, Ultrasonic IYO
Transducer, Ultrasonic, Diagnostic ITX
System, Imaging, Pulsed Doppler, Ultrasonic IYN
Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days LJS
System, Image Processing, Radiological LLZ

Proprietary Names

SonoEye P6/ SonoEye V6/ SonoEye G6 Digital Color Doppler Palm Ultrasound System ECO Series Diagnostic Ultrasound Systems C3-A,MC3-A,,V6-A,L7M-A,L7S-A,R7-A,P3-A,MC6-A ECO 1/ECO 2 /ECO 3/ECO 5/ECO 6Diagnostic Ultrasound Systems Sherlock 3CG+ Tip Confirmation System (TCS) Site~Rite Halcyon Diagnostic Ultrasound System C3,L7SVA,P3 SonoEye P5/ SonoEye V5/ SonoEye G5 Digital Color Doppler Palm Ultrasound System QBit Series Diagnostic Ultrasound System D7C10L, D7BC8, V6C10L, D6C15L, D3C20L, D3P64L, D2P64L, D6P64L, D2D16L, T5P64L, MT5P48L Diagnostic Ultrasound Transducer D3C60L, D5C40L, D3C50L, M3C60L,D7L40L, M7L40L, D7L60L, D12L40L Diagnostic Ultrasound Transducer D7L30L, M10L60L,D7L40L-REC,D6C12L, V4C40L, D7C10W,D5C20L, M7C10L Diagnostic Ultrasound Transducer QBit 1/QBit 2/ QBit 3/ QBit 4/QBit 5/QBit 6/QBit 7/QBit 8/QBit 9/ QBit 10/QBit 11/QBit 12 Diagnostic Ultrasound System SonoAir 10/20/30/40/50/60/70/80/90 Digital Color Doppler Ultrasound System 7L/3S/ 3C/ 6MC/ 6E SonoEye P3/ SonoEye V3/ Sono Eye G3 Digital Color Doppler Palm Ultrasound System C3-V,C3M-V, C3T-V,L7-V, L7SVA-V,L8Mb-V,L12b-V,L8M-V,L12-V, L12M-V SonoBook 6 SonoBook 2 SonoBook 8 R7B8-V,MC3-V,MC6-V,P2-V, P3T-V, P5-V,VE6-V SonoBook 7 SonoBook 4 SonoBook 9 SonoBook 1 L10i-V,L8M5-V,L18-V,R7-V,CW2-V,VC4-V,T5-V,E6-V,E7W-V,E7MW-V SonoBook 5 SonoBook 3 CBit 1/2/3/4/5/6/7/8/9/10Digital Color Doppler Ultrasound System the Viamo C100 (TUS-VC100) transducers SonoEye P2/ SonoEye V2/ SonoEye G2 Digital Color Doppler Palm Ultrasound System VC4-T,E7MW-T,R7B8-T,E7B7-T, VE6-T, MC6-T,MC3-T,P3T-T,P2-T,P2M-T,P5-T, CW2-T, T5-T, MT5-T C3-T,C3S-T,C3M-T,C3H-T,C3MS-T,C3T-T, L7-T,L7M-T,L12-T,L18-T,L7SVA-T,L8M-T,L8M5-T, L12M-T,L8M6-T ,L7R-T, L10i-T,E6-T,E7-T XBit 10/XBit 20/XBit 30/XBit 40/XBit 50/XBit 60/XBit 70/ XBit 80/XBit 90 Digital Color Doppler Ultrasound System V4-EV,V6-EV,MC3-E,MC5-E,MC6-E,C3S-D,L12-D,V7-D,L7-ES Diagnostic Ultrasound Transducer EBit10/EBit 20/EBit 30/EBit 40/EBit 50/EBit 60/EBit 70/EBit 80/EBit 90 Diagnostic Ultrasound System C3S-ES,P2-ES,V7-ES,7B8-E,T5-E,MT5-E,CW2-E,L18-E,i7L-E Diagnostic Ultrasound Transducer C3-E,C3S-E,L7-E,L7W-E,L12-E,P2-E,P3-E,P6-E,V6-E,V7W-E,V7-E,L7R-E Diagnostic Ultrasound Transducer IYN IYO SonoPort 2, SonoPort 2 Exp, SonoPort 2 Pro, SonoPort 2 Elite, SonoPort 2 Plus IYN IYO SonoPort 8, SonoPort 8 Exp, SonoPort 8 Pro, SonoPort 8 Elite, SonoPort 8 Plus IYN IYO SonoPort 7, SonoPort 7 Exp, SonoPort 7 Pro, SonoPort 7 Elite, SonoPort 7 Plus IYN IYO SonoPort 6, SonoPort 6 Exp, SonoPort 6 Pro, SonoPort 6 Elite, SonoPort 6 Plus IYN IYO SonoPort 9, SonoPort 9 Exp, SonoPort 9 Pro, SonoPort 9 Elite, SonoPort 9 Plus IYN IYO SonoPort Series Digital Color Doppler Ultrasound System IYN IYOSonoPort 1, SonoPort 1 Exp, SonoPort 1 Pro, SonoPort 1 Elite, SonoPort 1 Plus ITX P5,C2-9,E4-10,C2-6,C4-11,E4-13,BL3-12,S1-5P,S1-5,S2-8,S4-12,MS1-5,S3-7,S4-10,VE4-10,V2-6,CW2,T4-6,MT4-6 IYN IYO SonoPort 4, SonoPort 4 Exp, SonoPort 4 Pro, SonoPort 4 Elite, SonoPort 4 Plus ITX L4-10,L3-10,L6-18,L4-15B,L6-15i, L4-10R,L3-8,L5-14,L11-20,LA1-15,P2WS,P2,ML4-6,MC1-5,C1-5,C1-7,C1-7P,C3-12,C1-6,3C IYN IYO SonoPort 5, SonoPort 5 Exp, SonoPort 5 Pro, SonoPort 5 Elite, SonoPort 5 Plus IYN IYO SonoPort 3, SonoPort 3 Exp, SonoPort 3 Pro, SonoPort 3 Elite, SonoPort 3 Plus Medical image management and processing system,SiteRite™ 9 Ultrasound System Diagnostic Ultrasound Transducer,SiteRite™ 9 Ultrasound System SiteRite™ 9 Ultrasound System SonoMax 7 Super/SonoMax 7 EXP/ SonoMax 8/ SonoMax 8 Super/ SonoMax 8 EXP SonoMax Series Digital Color Doppler Ultrasound System SonoMax 9/SonoMax 9 Super/ SonoMax 9 EXP/SonoMax 10/ SonoMax 11/ SonoMax 22 SonoMax 1/ SonoMax 2/ SonoMax 3/ SonoMax 5/ SonoMax 6/SonoMax 7 SonoEye P1/ SonoEye P1-G/ SonoEye V1/ SonoEye V1-G/ SonoEye G1/ SonoEye G1-G Digital Color Doppler Palm Ultrasound System

Establishment Types

Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)