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Sign in to claim this brandAmsinomed Medical Co., Ltd
US
Last updated May 30, 2026
What Amsinomed Medical Co., Ltd makes
Amsinomed Medical Co., Ltd produces torque manipulation devices designed to apply rotational force to guidewires, aiding in medical procedures requiring precise wire control.
Their torque devices are classified as Class I medical devices and are listed in the FDA’s Unique Device Identifier (UDI) database, reflecting their regulatory compliance in the United States.
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 Amsinomed Medical Co., Ltd manufacture?
Amsinomed Medical Co., Ltd specializes in torque manipulation devices. These tools are specifically designed to apply rotational force to guidewires, which is essential in medical procedures where precise control of the guidewire’s movement is required. Their focus is on devices that assist in navigating and manipulating wires within the body.
Where is Amsinomed Medical Co., Ltd based?
Amsinomed Medical Co., Ltd is based in the United States. This location is relevant for understanding the regulatory environment under which their devices are developed and marketed, particularly in compliance with U.S. medical device regulations.
Which regulatory registries list Amsinomed Medical Co., Ltd’s devices?
Amsinomed Medical Co., Ltd’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is used to track and identify medical devices in the United States, ensuring transparency and traceability for regulatory purposes.
How are Amsinomed Medical Co., Ltd’s torque manipulation devices classified?
Amsinomed Medical Co., Ltd’s torque manipulation devices are classified as Class I medical devices. This classification is determined by the FDA based on the risk associated with the device. Class I devices are generally considered to pose the lowest risk and often involve minimal controls, though they must still meet regulatory requirements for safety and effectiveness.
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
- 545137135
Catalogue (11)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Torque Device for Guidewire | MZCH-3-10 | FDA UDI | Class I | Active |
| Torque Device for Guidewire | MZCH-3-8 | FDA UDI | Class I | Active |
| Torque Device for Guidewire | MZCH-3-12 | FDA UDI | Class I | Active |
| Torque Device for Guidewire | MZCH-1-5 | FDA UDI | Class I | Active |
| Torque Device for Guidewire | MZCH-1-10 | FDA UDI | Class I | Active |
| Torque Device for Guidewire | MZCH-2-8 | FDA UDI | Class I | Active |
| Torque Device for Guidewire | MZCH-2-5 | FDA UDI | Class I | Active |
| Torque Device for Guidewire | MZCH-1-8 | FDA UDI | Class I | Active |
| Torque Device for Guidewire | MZCH-1-12 | FDA UDI | Class I | Active |
| Torque Device for Guidewire | MZCH-2-12 | FDA UDI | Class I | Active |
| Torque Device for Guidewire | MZCH-2-10 | FDA UDI | Class I | Active |
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