Sonoscape Medical Corp.
Manufacturer and brand owner in Shenzhen, Guangdong, China. 7 device types, 10 products catalogued, 48 clearances.
Sonoscape Medical Corp. is a manufacturer holding a current FDA establishment registration. The registration covers Biopsy Needle Guide Kit, Transducer, Ultrasonic, Diagnostic and 5 other device types. 9 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2013.
7device types registered with the FDA
10products catalogued under its own name
48510(k) clearances
Registration
| Registered name | SONOSCAPE MEDICAL CORP. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3004705634 |
| FEI number | 3004705634 |
| DUNS | 545342185 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 深圳开立生物医疗科技股份有限公司 |
|---|---|
| Unified social credit code | 91440300743219767A |
| Source | export sales certificate, Guangdong medical products administration |
Location
| City | Shenzhen |
|---|---|
| Province | Guangdong |
| Address | Room 201 & 202, 12th Building, Shenzhen Software Park Phase II, 1 Keji Middle 2nd Road, Yuehai Subdistrict |
| Postal code | 518057 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Biopsy Needle Guide Kit | Class 2 | Biopsy Bracket | 2025 | 4 |
| Colonoscope And Accessories, Flexible/Rigid | Class 2 | EC-550T Video Colonoscope, VLS-55Q Light Source, EC-550 Video Colonoscope, EG-550L Video Gastroscope, EC-550L/T Video Colonoscope, EG-550 Video Gastroscope and 7 more | 2022 | 9 |
| Endoscope, Accessories, Narrow Band Spectrum | Class 2 | EC-550T Video Colonoscope, VLS-55Q Light Source, EC-550 Video Colonoscope, EG-550L Video Gastroscope, EC-550L/T Video Colonoscope, EG-550 Video Gastroscope and 7 more | 2022 | 3 |
| Gastroscope And Accessories, Flexible/Rigid | Class 2 | EC-550T Video Colonoscope, VLS-55Q Light Source, EC-550 Video Colonoscope, EG-550L Video Gastroscope, EC-550L/T Video Colonoscope, EG-550 Video Gastroscope and 7 more | 2022 | 9 |
| System, Imaging, Pulsed Doppler, Ultrasonic | Class 2 | X10 Elite Digital Color Doppler Ultrasound System, SU11A EXP Digital Color Doppler Ultrasound System, ER3 Digital Color Doppler Ultrasound System, SU11C EXP Digital Color Doppler Ultrasound System, X10U Digital Color Doppler Ultrasound System, SU11C PRO Digital Color Doppler Ultrasound System and 173 more | 2013 | 22 |
| System, Imaging, Pulsed Echo, Ultrasonic | Class 2 | X10 Elite Digital Color Doppler Ultrasound System, SU11A EXP Digital Color Doppler Ultrasound System, ER3 Digital Color Doppler Ultrasound System, SU11C EXP Digital Color Doppler Ultrasound System, X10U Digital Color Doppler Ultrasound System, SU11C PRO Digital Color Doppler Ultrasound System and 173 more | 2013 | 37 |
| Transducer, Ultrasonic, Diagnostic | Class 2 | X10 Elite Digital Color Doppler Ultrasound System, SU11A EXP Digital Color Doppler Ultrasound System, ER3 Digital Color Doppler Ultrasound System, SU11C EXP Digital Color Doppler Ultrasound System, X10U Digital Color Doppler Ultrasound System, SU11C PRO Digital Color Doppler Ultrasound System and 173 more | 2013 | 44 |
Own-Brand Listings
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K254027 | 2026-08-24 | IYN | Traditional | This company |
| K254028 | 2026-05-15 | IYN | Traditional | This company |
| K252498 | 2025-12-05 | IYN | Traditional | This company |
| K241949 | 2025-01-17 | IYN | Traditional | This company |
| K231813 | 2024-03-08 | ODG | Traditional | This company |
| K222596 | 2023-02-10 | IYN | Traditional | This company |
| K221089 | 2022-09-15 | IYN | Traditional | This company |
| K221140 | 2022-09-13 | IYN | Traditional | This company |
| K222020 | 2022-09-08 | NWB | Traditional | This company |
| K211882 | 2022-04-01 | NWB | Traditional | This company |
| K201059 | 2020-07-30 | IYN | Traditional | This company |
| K182648 | 2019-01-29 | IYN | Traditional | This company |
| K173921 | 2018-09-05 | NWB | Traditional | This company |
| K172993 | 2017-12-05 | IYN | Traditional | This company |
| K173058 | 2017-12-01 | IYN | Traditional | This company |
| K172082 | 2017-09-21 | IYN | Traditional | This company |
| K170999 | 2017-07-12 | IYN | Traditional | This company |
| K171000 | 2017-07-11 | IYN | Traditional | This company |
| K170303 | 2017-05-19 | IYN | Traditional | This company |
| K163427 | 2017-01-03 | IYN | Special | This company |
| K160283 | 2016-04-04 | IYN | Traditional | This company |
| K160258 | 2016-04-01 | IYN | Traditional | This company |
| K152854 | 2016-01-13 | IYN | Traditional | This company |
| K152396 | 2015-09-03 | IYN | Special | This company |
| K152164 | 2015-08-28 | IYN | Special | This company |
| K152165 | 2015-08-26 | IYN | Special | This company |
| K150045 | 2015-04-28 | IYN | Traditional | This company |
| K142714 | 2015-01-29 | IYN | Traditional | This company |
| K142815 | 2015-01-28 | IYN | Traditional | This company |
| K142710 | 2015-01-05 | IYN | Traditional | This company |
| K142474 | 2014-12-19 | IYN | Traditional | This company |
| K132527 | 2013-11-14 | IYN | Traditional | This company |
| K131262 | 2013-11-14 | DPS | Traditional | This company |
| K132768 | 2013-10-04 | IYN | Special | This company |
| K131213 | 2013-06-21 | IYN | Traditional | This company |
| K130801 | 2013-06-14 | IYN | Traditional | This company |
| K131088 | 2013-05-24 | IYN | Traditional | This company |
| K130119 | 2013-04-12 | IYN | Traditional | This company |
| K123616 | 2012-12-21 | IYO | Special | This company |
| K112602 | 2011-11-07 | IYN | Traditional | This company |
| K112451 | 2011-09-16 | IYN | Special | This company |
| K110510 | 2011-05-16 | IYN | Traditional | This company |
| K102642 | 2011-03-04 | IYN | Traditional | This company |
| K101337 | 2010-09-30 | IYO | Traditional | This company |
| K092922 | 2010-03-12 | IYN | Traditional | This company |
| K052042 | 2005-08-09 | IYN | Traditional | This company |
| K042369 | 2004-10-20 | IYN | Traditional | This company |
| K041455 | 2004-06-10 | IYO | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2002 |
|---|---|
| Employees | 3000+ |
| Main products | Ultrasound imaging systems, Endoscopy systems, Minimally invasive surgery equipment, Cardiovascular intervention devices, Veterinary ultrasound |
| Certifications | CE-Mark EU-MDR, SGS certification, TÜV Rheinland CTF, CNAS Laboratory Accreditation, FDA, National Enterprise Technology Center |
| Export markets | 170+ countries and regions |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.