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Sign in to claim this brandKolo Medical (Suzhou) Co., Ltd.
US
Last updated May 24, 2026
What Kolo Medical (Suzhou) Co., Ltd. makes
Kolo Medical (Suzhou) Co., Ltd. makes general-purpose ultrasound imaging systems and extracorporeal ultrasound imaging transducers, including hand-held devices. Their products include the KOLO Evolution XHD Series Ultrasound Diagnostic System.
The company's portfolio is regulated as Class II devices and is listed in the FDA 510(k) and FDA UDI registries. The company is based in the US.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What does Kolo Medical (Suzhou) Co., Ltd. manufacture?
Kolo Medical produces general-purpose ultrasound imaging systems and extracorporeal ultrasound imaging transducers, including hand-held devices. Their product line includes the KOLO Evolution XHD Series Ultrasound Diagnostic System.
Where is Kolo Medical (Suzhou) Co., Ltd. based?
The company is based in the United States, as indicated in the regulatory registry data.
Which regulatory registries list Kolo Medical's devices?
Kolo Medical's devices are listed in the FDA 510(k) and FDA UDI registries, which track medical devices cleared through the premarket notification process and their unique device identifiers.
How are Kolo Medical's devices classified?
Kolo Medical's devices are regulated as Class II medical devices, which means they require special controls to ensure their safety and effectiveness, but are generally considered lower risk than Class III devices.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 550397899
Catalogue (11)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Kolo | Evolution XHD 70 | FDA UDI | Class II | Active |
| Kolo | Evolution XHD 65 | FDA UDI | Class II | Active |
| Kolo | Evolution XHD 60 | FDA UDI | Class II | Active |
| Kolo | L62-38K2 | FDA UDI | Class II | Active |
| Kolo | L28-12K2 | FDA UDI | Class II | Active |
| Kolo | L38-22K2 | FDA UDI | Class II | Active |
| Kolo | Evolution XHD 55 | FDA UDI | Class II | Active |
| Kolo | Evolution XHD 80 | FDA UDI | Class II | Active |
| Kolo | L22-8K2 | FDA UDI | Class II | Active |
| Kolo | Evolution XHD 50 | FDA UDI | Class II | Active |
| KOLO Evolution XHD Series Ultrasound Diagnostic System | K221568 | FDA 510(k) | Class II | Active |
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