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Sign in to claim this brandCHISON Medical Technologies Co., Ltd.
US
Last updated May 23, 2026
What CHISON Medical Technologies Co., Ltd. makes
The company manufactures diagnostic ultrasound systems and associated transducers, including hand-held extracorporeal probes, rectal and vaginal probes, and reusable oesophageal probes. Their portfolio also includes general-purpose ultrasound systems, foetal Doppler probes, and utility trolleys for medical imaging. Specific product lines like the ECO and SonoTouch Series provide imaging solutions with linear, convex, phased array, and volume probes tailored for various clinical applications.
These devices are classified as Class II under regulatory frameworks and are listed in the FDA’s Unique Device Identifier (UDI) database. The company operates from the United States, adhering to applicable medical device regulations for diagnostic imaging equipment.
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 Chison Medical Technologies Co., Ltd. manufacture?
Chison Medical Technologies Co., Ltd. specializes in diagnostic ultrasound systems and related imaging tools. Their portfolio includes hand-held extracorporeal ultrasound transducers, rectal and vaginal ultrasound probes, reusable oesophageal ultrasound probes, general-purpose ultrasound imaging systems, and foetal Doppler system probes. They also produce utility trolleys designed to support these imaging devices. These products are developed to meet diverse clinical needs, such as obstetrics, cardiology, and gastrointestinal assessments.
Where is Chison Medical Technologies Co., Ltd. based, and how does this affect its regulatory compliance?
Chison Medical Technologies Co., Ltd. is based in the United States. As a US-based manufacturer, the company must comply with FDA regulations governing medical devices. Their devices fall under the FDA’s Unique Device Identifier (UDI) database, ensuring traceability and transparency in the supply chain. Compliance with US regulatory standards is critical for market access and patient safety, particularly for Class II devices like those produced by Chison.
Which regulatory registries list Chison Medical Technologies Co., Ltd.’s devices, and why is this important?
Chison Medical Technologies Co., Ltd.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is essential because it provides a standardized way to identify medical devices throughout their lifecycle, from manufacturing to patient use. Listing in the UDI database ensures traceability, helps healthcare providers verify device details, and supports regulatory oversight, particularly for Class II devices like ultrasound systems and transducers.
How are Chison Medical Technologies Co., Ltd.’s devices classified under regulatory frameworks, and what does this mean?
Chison Medical Technologies Co., Ltd.’s devices are classified as Class II under regulatory frameworks. This classification indicates that while they pose moderate risk, they require special controls beyond general controls to ensure safety and effectiveness. For example, ultrasound systems and transducers fall into this category because they involve patient contact and require validation of performance, sterility, and imaging accuracy. Class II status means additional scrutiny, such as pre-market notifications or post-market surveillance, to maintain compliance and patient safety.
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
- 544914187
Catalogue (173)
Page 3 of 4| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Linear probe | D7L30L | FDA UDI | Class II | Active |
| Q Series Diagnostic Ultrasound System | Q5 | FDA UDI | Class II | Active |
| Digital Color Doppler Palm Ultrasound System | SonoEye P6 | FDA UDI | Class II | Active |
| Micro convex probe | D6C15L-A | FDA UDI | Class II | Active |
| Volume probe | V6-EV | FDA UDI | Class II | Active |
| Convex probe | D6C10L | FDA UDI | Class II | Active |
| Micro convex probe | MC6-E | FDA UDI | Class II | Active |
| Linear probe | D7L40L-REC | FDA UDI | Class II | Active |
| Micro convex probe | V6-A | FDA UDI | Class II | Active |
| Linear probe | M7L40L | FDA UDI | Class II | Active |
| Linear probe | L12-V | FDA UDI | Class II | Active |
| Phased array probe | P2M-T | FDA UDI | Class II | Active |
| Linear probe | L8M6-T | FDA UDI | Class II | Active |
| Volume probe | V6C10L | FDA UDI | Class II | Active |
| Convex probe | C3M-T | FDA UDI | Class II | Active |
| Micro convex probe | V7-E | FDA UDI | Class II | Active |
| line array probe | L12M-T | FDA UDI | Class II | Active |
| Linear probe | L8Mb-V | FDA UDI | Class II | Active |
| i7 Diagnostic Ultrasound System | i7 | FDA UDI | Class II | Active |
| Convex probe | C3-V | FDA UDI | Class II | Active |
| Tee probe | T5P64L | FDA UDI | Class II | Active |
| Convex probe | D5C40L | FDA UDI | Class II | Active |
| Convex probe | MC6-A | FDA UDI | Class II | Active |
| SonoBokk Series Diagnostic Ultrasound Systems | SonoBook 6 | FDA UDI | Class II | Active |
| Convex probe | MC3-A | FDA UDI | Class II | Active |
| Linear probe | L12M-V | FDA UDI | Class II | Active |
| Volume probe | V4C40L-C | FDA UDI | Class II | Active |
| Phased array probe | P5-T | FDA UDI | Class II | Active |
| Linear probe | R7-A | FDA UDI | Class II | Active |
| Linear probe | L7-V | FDA UDI | Class II | Active |
| Linear probe | L8M5-T | FDA UDI | Class II | Active |
| Tee probe | MT5P48L | FDA UDI | Class II | Active |
| CBit Series Digital Color Doppler Ultrasound System | CBit 10 | FDA UDI | Class II | Active |
| Linear probe | L8M-V | FDA UDI | Class II | Active |
| Micro convex probe | E7MW-T | FDA UDI | Class II | Active |
| Volume probe | V4C40L | FDA UDI | Class II | Active |
| Micro convex probe | 7B8-E | FDA UDI | Class II | Active |
| Tee probe | T5-V | FDA UDI | Class II | Active |
| Linear probe | L7M-A | FDA UDI | Class II | Active |
| CBit Series Digital Color Doppler Ultrasound System | CBit 9 | FDA UDI | Class II | Active |
| Micro convex probe | MC3-E | FDA UDI | Class II | Active |
| ECO Series Diagnostic Ultrasound Systems | ECO 5 | FDA UDI | Class II | Active |
| Linear probe | M8L60L | FDA UDI | Class II | Active |
| Linear probe | L12b-V | FDA UDI | Class II | Active |
| EBit Series Diagnostic Ultrasound System | EBit 50 | FDA UDI | Class II | Active |
| Pencil probe | D2D16L | FDA UDI | Class II | Active |
| Q Series Trolly | TR-2 | FDA UDI | Class II | Active |
| Linear probe | D10L40L | FDA UDI | Class II | Active |
| Convex probe | H3C60L | FDA UDI | Class II | Active |
| SonoBook Series Diagnostic Ultrasound Systems | SonoBook 5 | FDA UDI | Class II | Active |
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- CHISON Medical Technologies Co., Ltd. WUXI Jiangsu · CN FEI 3004753388