FDA Registration
Active
🇨🇳 China
SONOSCAPE MEDICAL CORP.
Reg #: 3004705634
·
FEI: 3004705634
·
Expires 2026
Products
7
Proprietary Names
193
Establishment Types
1
Classifications
7
Registration Details
- Registration Name
- SONOSCAPE MEDICAL CORP.
- Registration Number
- 3004705634
- FEI Number
- 3004705634
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Room 201 & 202, 12th Building, Shenzhen Software Park Phase II, 1 Keji Middle 2nd Road, Yuehai Subdistrict, Nanshan District,
- City
- SHENZHEN Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K254028
Owner / Operator
- Firm Name
- SONOSCAPE MEDICAL CORP.
- Operator Number
- 9063868
- Address
- Room 201 & 202, 12th Building, Shenzhen Software Park Phase II, 1 Keji Middle 2nd Road, Yuehai Subdistrict, Nanshan District,
- City
- Shenzhen
- State
- Guangdong
- Postal Code
- 518057
- Country
- CN
- Correspondent
- Toki - Wu
US Agent
- Business Name
- Bioprober Corporation
- Contact Name
- Xuegong Shi
- Address
- 1975 112TH AVE NE STE 101
- City
- Bellevue
- State
- WA
- ZIP
- 98004
- Country
- US
- [email protected]
- Phone
- 425 9744253
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Imaging, Pulsed Doppler, Ultrasonic | IYN | Class 2 | Radiology | No | 2026-05-25 |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | Class 2 | Radiology | No | 2026-05-25 |
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2026-05-25 |
| Endoscope, Accessories, Narrow Band Spectrum | NWB | Class 2 | Gastroenterology, Urology | No | 2022-09-19 |
| Colonoscope And Accessories, Flexible/Rigid | FDF | Class 2 | Gastroenterology, Urology | No | 2022-09-19 |
| Gastroscope And Accessories, Flexible/Rigid | FDS | Class 2 | Gastroenterology, Urology | No | 2022-09-19 |
| Biopsy Needle Guide Kit | OIJ | Class 2 | Radiology | No | 2025-09-29 |
Proprietary Names
Autra 70 Elite Digital Color Doppler Ultrasound System
Autra CV Digital Color Doppler Ultrasound System
Autra 65 Digital Color Doppler Ultrasound System
Autra T Digital Color Doppler Ultrasound System
Autra 90 Digital Color Doppler Ultrasound System
Autra 90 Elite Digital Color Doppler Ultrasound System
Autra 65i Digital Color Doppler Ultrasound System
Autra 80W Digital Color Doppler Ultrasound System
Autra RS Digital Color Doppler Ultrasound System
Autra 55i Digital Color Doppler Ultrasound System
Autra 90 CV Digital Color Doppler Ultrasound System
Autra 75 Pro Digital Color Doppler Ultrasound System
Autra 80 Elite Digital Color Doppler Ultrasound System
Autra 85 Elite Digital Color Doppler Ultrasound System
Autra 85 Digital Color Doppler Ultrasound System
Autra 75W Digital Color Doppler Ultrasound System
Autra 85 CV Digital Color Doppler Ultrasound System
e-Autra Digital Color Doppler Ultrasound System
Autra 55 Elite Digital Color Doppler Ultrasound System
Autra 75 Digital Color Doppler Ultrasound System
Autra 80 Digital Color Doppler Ultrasound System
Autra Senior Digital Color Doppler Ultrasound System
Autra 75 Elite Digital Color Doppler Ultrasound System
Autra 80 CV Digital Color Doppler Ultrasound System
Autra 65 Elite Digital Color Doppler Ultrasound System
Autra 85W Digital Color Doppler Ultrasound System
Autra 55 Digital Color Doppler Ultrasound System
Autra 70 Digital Color Doppler Ultrasound System
P10 Series
P20 Elite Digital Color Doppler Ultrasound System
P20 Exp Digital Color Doppler Ultrasound System
P15 Exp Digital Color Doppler Ultrasound System
P25 Exp Digital Color Doppler Ultrasound System
P22 Elite Digital Color Doppler Ultrasound System
P25 Elite Digital Color Doppler Ultrasound System
P15 Elite Digital Color Doppler Ultrasound System
P22 Exp Digital Color Doppler Ultrasound System
EC-550L Video Colonoscope
VLS-55Q Light Source
VLS-51D Light Source
EG-550L Video Gastroscope
VLS-51T Light Source
EC-550T Video Colonoscope
HD-550 Image Processor
HD-550S Image Processor
EC-550 Video Colonoscope
EC-550L/T Video Colonoscope
VLS-55T Light Source
HD-500Plus Image Processor
EG-550 Video Gastroscope
P60 Exp Digital Color Doppler Ultrasound System
P55 Digital Color Doppler Ultrasound System
P55 Elite Digital Color Doppler Ultrasound System
P40T Digital Color Doppler Ultrasound System
P60S Digital Color Doppler Ultrasound System
P50 Elite Digital Color Doppler Ultrasound System
P25S Digital Color Doppler Ultrasound System
P60 VO Digital Color Doppler Ultrasound System
P40E Digital Color Doppler Ultrasound System
P60 Pro Digital Color Doppler Ultrasound System
P30T Digital Color Doppler Ultrasound System
P50E Digital Color Doppler Ultrasound System
P70S Digital Color Doppler Ultrasound System
P60 CV Digital Color Doppler Ultrasound System
P22S Digital Color Doppler Ultrasound System
P30 Elite Digital Color Doppler Ultrasound System
P70T Digital Color Doppler Ultrasound System
P30E Digital Color Doppler Ultrasound System
P40 Elite Digital Color Doppler Ultrasound System
P50T Digital Color Doppler Ultrasound System
P55S Digital Color Doppler Ultrasound System
P60 Digital Color Doppler Ultrasound System
SonoStage M1 Digital Color Doppler Ultrasound System
X5 Series Digital Color Doppler Ultrasound System
P20 Series
X3 Series Digital Colro Doppler Ultrasound System
S9 Exp Portable Digital Color Doppler Ultrasound System
S9 Portable Digital Color Doppler Ultrasound System
S60 Elite&S70 Series Digital Color Doppler Ultrasound
P12N Digital Color Doppler Ultrasound System
P11 Pro Digital Color Doppler Ultrasound System
R11 Digital Color Doppler Ultrasound System
P11 Elite Digital Color Doppler Ultrasound System
P9 Elite Digital Color Doppler Ultrasound System
P10N Digital Color Doppler Ultrasound System
P12 Pro Digital Color Doppler Ultrasound System
R10 Digital Color Doppler Ultrasound System
P12 Exp Digital Color Doppler Ultrasound System
R9 Digital Color Doppler Ultrasound System
P11N Digital Color Doppler Ultrasound System
P12 Elite Digital Color Doppler Ultrasound System
P11 Exp Digital Color Doppler Ultrasound System
M11 Digital Color Doppler Ultrasound System
R12/P12N/P11 Exp/P11 Elite/P11 Pro/ R11/P11N/P10 Elite/P10N/R10/P9 Elite/M11/R9
P10 Elite Digital Color Doppler Ultrasound System
P50 Series Digital Color Doppler Ultrasound System
S2 Portable Digital Color Doppler ultrasound System
S30/S40 Digital Color Doppler Ultrasound System
S60 Series Digital Color Doppler Ultrasound System
Biopsy Bracket
S50 Digital Color Doppler Ultrasound System
S12 Digital Color Doppler Ultrasound System
E11 Plus Digital Color Doppler Ultrasound System
X10 Pro Digital Color Doppler Ultrasound System
XR1 Digital Color Doppler Ultrasound System
ER1 Digital Color Doppler Ultrasound System
E11s Digital Color Doppler Ultrasound System
SU11C PRO Digital Color Doppler Ultrasound System
SU11B PRO Digital Color Doppler Ultrasound System
X11 Super Digital Color Doppler Ultrasound System
E10T Digital Color Doppler Ultrasound System
X10s Digital Color Doppler Ultrasound System
X11 Plus Digital Color Doppler Ultrasound System
SU11A EXP Digital Color Doppler Ultrasound System
SU11A CU Digital Color Doppler Ultrasound System
SU11B EXP Digital Color Doppler Ultrasound System
SU11B CU Digital Color Doppler Ultrasound System
E10 Plus Digital Color Doppler Ultrasound System
X11 Digital Color Doppler Ultrasound System
X10 Digital Color Doppler Ultrasound System
X10T Digital Color Doppler Ultrasound System
SU11B AD Digital Color Doppler Ultrasound System
X10 Senior Digital Color Doppler Ultrasound System
XR3 Digital Color Doppler Ultrasound System
E11 Pro Digital Color Doppler Ultrasound System
E11 Digital Color Doppler Ultrasound System
X10 Elite Digital Color Doppler Ultrasound System
X11U Digital Color Doppler Ultrasound System
X10i Digital Color Doppler Ultrasound System
X11i Digital Color Doppler Ultrasound System
SU11A AD Digital Color Doppler Ultrasound System
XR2 Digital Color Doppler Ultrasound System
X11R Digital Color Doppler Ultrasound System
X11s Digital Color Doppler Ultrasound System
X11 Pro Digital Color Doppler Ultrasound System
X11T Digital Color Doppler Ultrasound System
E11i Digital Color Doppler Ultrasound System
X10 Super Digital Color Doppler Ultrasound System
E10 Digital Color Doppler Ultrasound System
X10 Exp Digital Color Doppler Ultrasound System
E10 Pro Digital Color Doppler Ultrasound System
ER3 Digital Color Doppler Ultrasound System
SU11C EXP Digital Color Doppler Ultrasound System
ER2 Digital Color Doppler Ultrasound System
SU11C AD Digital Color Doppler Ultrasound System
E10i Digital Color Doppler Ultrasound System
X10 Plus Digital Color Doppler Ultrasound System
X11 Senior Digital Color Doppler Ultrasound System
X11 Elite Digital Color Doppler Ultrasound System
X11 Exp Digital Color Doppler Ultrasound System
E11T Digital Color Doppler Ultrasound System
E10s Digital Color Doppler Ultrasound System
SU11A PRO Digital Color Doppler Ultrasound System
X10R Digital Color Doppler Ultrasound System
E11 Elite Digital Color Doppler Ultrasound System
X10U Digital Color Doppler Ultrasound System
SU11C CU Digital Color Doppler Ultrasound System
S11 Digital Color Doppler Ultrasound System
I80-Surg Digital Color Doppler Ultrasound System
I70-Endo Digital Color Doppler Ultrasound System
S80 Exp Digital Color Doppler Ultrasound System
P80T Digital Color Doppler Ultrasound System
P70i Digital Color Doppler Ultrasound System
P80 Pro Digital Color Doppler Ultrasound System
S80 Digital Color Doppler Ultrasound System
P90i Digital Color Doppler Ultrasound System
S90 Exp Digital Color Doppler Ultrasound System
S80 Senior Digital Color Doppler Ultrasound System
P80 Elite Digital Color Doppler Ultrasound System
P80 Senior Digital Color Doppler Ultrasound System
P80 Exp Digital Color Doppler Ultrasound System
S80 Elite Digital Color Doppler Ultrasound System
P80 Plus Digital Color Doppler Ultrasound System
I75-Endo Digital Color Doppler Ultrasound System
S80T Digital Color Doppler Ultrasound System
S80 Pro Digital Color Doppler Ultrasound System
S70i Digital Color Doppler Ultrasound System
S80 Plus Digital Color Doppler Ultrasound System
P80 Super Digital Color Doppler Ultrasound System
P80 Digital Color Doppler Ultrasound System
S80 Super Digital Color Doppler Ultrasound System
S100 Exp Digital Color Doppler Ultrasound System
I80-Endo Digital Color Doppler Ultrasound System
S45 Digital Color Doppler Ultrasound System
S2 Exp Portable Digital Color Doppler Ultrasound System
SSI-980 Portable Digital Color Doppler Ultrasound System
S2s Portable Digital Color Doppler Ultrasound System
S6s Portable Digital Color Doppler Ultrasound System
S9 Pro Portable Digital Color Doppler Ultrasound System
S7 Portable Digital Color Doppler Ultrasound System
S8 Exp Portable Digital Color Doppler Ultrasound System
E5 Series Digital Color Doppler Ultrasound System
S22 Digital Color Doppler Ultrasound System
Establishment Types
Manufacture Medical Device