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Sign in to claim this brandSONOSCAPE MEDICAL CORP.
China·CN-MF-000009623
Last updated September 17, 2026
Part of Sonoscape Medical Corp.
What SONOSCAPE MEDICAL CORP. makes
Sonoscape Medical Corp. manufactures handheld extracorporeal ultrasound imaging transducers, including rectal, vaginal, oesophageal, and surgical variants, as well as reusable oesophageal models. Their portfolio includes general-purpose ultrasound imaging systems and endoscopic accessories, such as line-powered light sources and video processing units for endoscopic procedures. Devices like the Marvo 80T, P85 Exp, and HE12 are designed for medical imaging applications requiring high-resolution ultrasound and endoscopic integration.
The company’s products are classified under EU Medical Device Regulations as Class I, Class II, Class IIa, and Class IIb, with corresponding registrations in eudamed, FDA 510(k), and FDA UDI. These devices are listed in global regulatory databases to support compliance tracking and market authorisation processes. The manufacturer operates from China.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Sonoscape Medical Corp. primarily manufacture?
Sonoscape Medical Corp. specializes in ultrasound-related medical devices, including handheld extracorporeal ultrasound imaging transducers for various applications like rectal, vaginal, oesophageal, and surgical use. Their portfolio also includes reusable oesophageal ultrasound transducers, general-purpose ultrasound imaging systems, and endoscopic accessories such as line-powered light sources and video processing units. These devices are designed to support high-resolution imaging and endoscopic procedures.
Where is Sonoscape Medical Corp. based, and how does this affect its regulatory compliance?
Sonoscape Medical Corp. is based in China. While the country of origin does not inherently determine regulatory classification, it influences compliance requirements for global markets. The company’s devices are listed in key regulatory databases like eudamed (EU), FDA 510(k), and FDA UDI (US), ensuring they meet the necessary standards for market authorization in those regions.
Which regulatory databases list Sonoscape Medical Corp.’s devices, and why is this important?
Sonoscape Medical Corp.’s devices are listed in eudamed (for EU compliance), FDA 510(k) (for US premarket submissions), and FDA UDI (for unique device identification). Listing in these databases is critical because it provides transparency for regulators, healthcare providers, and patients, ensuring traceability and compliance with global medical device regulations. It also supports post-market surveillance and risk management processes.
How are Sonoscape Medical Corp.’s devices classified under EU and US regulations?
Sonoscape Medical Corp.’s devices fall under EU Medical Device Regulations classifications of Class I, Class II, Class IIa, and Class IIb. The classification depends on factors like intended use, risk level, and interaction with the body—for example, surgical ultrasound transducers may carry higher risk and thus a stricter classification. In the US, similar risk-based categorization applies, though the exact FDA classification (e.g., Class I, II, or III) may differ from the EU system. These classifications determine the regulatory pathway for market authorization.
Why might a healthcare provider or regulator check if Sonoscape Medical Corp.’s devices are listed in eudamed or FDA databases?
Checking listings in eudamed or FDA databases ensures that a device has undergone the necessary regulatory processes to be legally marketed in the EU or US. For healthcare providers, this confirms the device’s compliance with safety and performance standards. For regulators, it validates that the manufacturer has met reporting obligations, such as UDI registration, which aids in tracking recalls, adverse events, and post-market surveillance. This transparency builds trust in the device’s legitimacy and safety.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- China
- Address
- 1 Keji Middle 2nd Road, Room 201 & 202, 12th Building, Shenzhen Software Park Phase II, 1 Keji Middle 2nd Road, Yuehai Subdistrict, Nanshan District, Shenzhen, Guangdong, China
- Website
- sonoscape.net
- —
- —
- [email protected]
- Phone
- +86-755-26722890
- PRRC Contact
- Yigang Yao
- EUDAMED SRN
- CN-MF-000009623
- FDA FEI Number
- 3015525240
- DUNS Number
- 545342185
Catalogue (917)
Page 3 of 19| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| SonoScape | S30 | FDA UDI | Class II | Active |
| SonoScape | C612 | FDA UDI | Class II | Active |
| SonoScape | C354 | FDA UDI | Class II | Active |
| SonoScape | L743 | FDA UDI | Class II | Active |
| Sonoscape | L742 | FDA UDI | Class II | Active |
| SonoScape | BCC9-5 | FDA UDI | Class II | Active |
| SonoScape | S12 | FDA UDI | Class II | Active |
| SonoScape | PWD2.0 | FDA UDI | Class II | Active |
| SonoScape | S50 | FDA UDI | Class II | Active |
| SonoScape | S2 | FDA UDI | Class II | Active |
| SonoScape | EC2 | FDA UDI | Class II | Active |
| Sonoscape | S60 Elite | FDA UDI | Class II | Active |
| Sonoscape | P10 | FDA UDI | Class II | Active |
| SonoScape | C344 | FDA UDI | Class II | Active |
| SonoScape | HD-500Plus | FDA UDI | Class II | Active |
| SonoScape | S8 Exp | FDA UDI | Class II | Active |
| SonoScape | L743 | FDA UDI | Class II | Active |
| SonoScape | X3 Pro | FDA UDI | Class II | Active |
| SonoScape | HD-550Pro | FDA UDI | Class II | Active |
| Sonoscape | 13L-A | FDA UDI | Class II | Active |
| SonoScape | C1-6 | FDA UDI | Class II | Active |
| SonoScape | MPTEE mini | FDA UDI | Class II | Active |
| SonoScape | C611 | FDA UDI | Class II | Active |
| sonoscape | PWD2.0 | FDA UDI | Class II | Active |
| SonoScape | S11 | FDA UDI | Class II | Active |
| SonoScape | S30 | FDA UDI | Class II | Active |
| SonoScape | MPTEE mini | FDA UDI | Class II | Active |
| SonoScape | L742 | FDA UDI | Class II | Active |
| SonoScape | C362 | FDA UDI | Class II | Active |
| SonoScape | S22 | FDA UDI | Class II | Active |
| SonoScape | S11 | FDA UDI | Class II | Active |
| SonoScape | C352 | FDA UDI | Class II | Active |
| SonoScape | MPTEE | FDA UDI | Class II | Active |
| SonoScape | S50 | FDA UDI | Class II | Active |
| SonoScape | C344 | FDA UDI | Class II | Active |
| SonoScape | A6 | FDA UDI | Class II | Active |
| SonoScape | PWD2.0 | FDA UDI | Class II | Active |
| Sonoscape | BCL10-5 | FDA UDI | Class II | Active |
| SonoScape | C362 | FDA UDI | Class II | Active |
| SonoScape | 13L-A | FDA UDI | Class II | Active |
| Digital Color Doppler Ultrasound System (Autra RS, Autra 90, Autra Senior, Autra CV, e-Autra, Autra 75, Autra 85W, Autra 65, Autra 55, Autra 65i, Autra 90 Elite, Autra 85 Elite, Autra 80 Elite, Autra 75 Elite, Autra 85 CV, Autra 80W, Autra 65 Elite, Autra 55 Elite, Autra 55i, Autra 90 CV, Autra 85, Autra 80, Autra 80 CV, Autra 75 Pro, Autra 75W, Autra 70 Elite, Autra 70, Autra T) | K254028 | FDA 510(k) | Class II | Active |
| SonoScape | CWD2.0 | FDA UDI | Class II | Active |
| SonoScape | S22 | FDA UDI | Class II | Active |
| SonoScape | C312 | FDA UDI | Class II | Active |
| SonoScape | VL12-5 | FDA UDI | Class II | Active |
| SonoScape | S9 Pro | FDA UDI | Class II | Active |
| 6ci-A | / | EUDAMEDFDA UDI | Class IIa | Active |
| Vc6-2 | - | EUDAMEDFDA UDI | Class IIa | Active |
| Bcl10-5 | / | EUDAMED | Class IIa | Active |
| C542 | / | EUDAMEDFDA UDI | Class IIa | Active |
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Sonoscape Medical Corp. Shenzhen Guangdong · CN FEI 3015525240