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
- [email protected]
- Phone
- 702 2095185
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | Class 2 | Radiology | No | 2021-02-25 |
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2021-02-25 |
| System, Imaging, Pulsed Doppler, Ultrasonic | IYN | Class 2 | Radiology | No | 2021-02-25 |
| Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | LJS | Class 2 | General Hospital | No | 2019-03-01 |
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2024-08-18 |
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)