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US
Last updated May 24, 2026
What MATSUM INC makes
Matsum Inc manufactures external electric-heating core temperature regulation system pads designed to maintain body temperature through controlled thermal output. These devices are intended for use in clinical or procedural settings where hypothermia risk is managed through external warming.
The company’s products are classified as Class II medical devices under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. Matsum Inc operates from 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 Matsum Inc manufacture?
Matsum Inc specializes in external electric-heating core temperature regulation system pads, which are designed to maintain a patient’s body temperature by delivering controlled thermal output. These devices are intended for clinical or procedural environments where preventing or managing hypothermia is critical.
Where is Matsum Inc based, and how does that affect its regulatory standing?
Matsum Inc is headquartered in the United States, which means its devices are subject to FDA regulations. The company’s products fall under Class II classification, indicating they pose moderate risk and require special controls to ensure safety and effectiveness.
Are Matsum Inc’s devices listed in any regulatory registries, and why does this matter?
Yes, Matsum Inc’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps healthcare providers, regulators, and manufacturers track specific devices by assigning them a unique code, improving transparency, recall management, and post-market surveillance.
How are Matsum Inc’s devices classified under FDA regulations, and what does that classification mean?
Matsum Inc’s external electric-heating core temperature regulation system pads are classified as Class II devices by the FDA. This classification means they are considered to have a moderate risk to patients and require compliance with special controls beyond general controls (like good manufacturing practices) to ensure safety and performance.
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
- 170636802
Catalogue (18)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Venture Heat | KB172418 | FDA UDI | Class II | Active |
| Venture Heat | KB171240 S/M | FDA UDI | Class II | Active |
| Venture Heat | KB171230 | FDA UDI | Class II | Active |
| Venture Heat | KB172472 | FDA UDI | Class II | Active |
| Venture Heat | KB171250 L/XL | FDA UDI | Class II | Active |
| Venture Heat | KB171260 S/M | FDA UDI | Class II | Active |
| Venture Heat | KB171210 | FDA UDI | Class II | Active |
| Venture Heat | KB171240 L/XL | FDA UDI | Class II | Active |
| Venture Heat | KB171260 L/XL | FDA UDI | Class II | Active |
| Venture Heat | KB171280 S/M | FDA UDI | Class II | Active |
| Venture Heat | KB171290 L/XL | FDA UDI | Class II | Active |
| Venture Heat | KB171290 S/M | FDA UDI | Class II | Active |
| Venture Heat | KB171250 S/M | FDA UDI | Class II | Active |
| Venture Heat | KB172436-GRY | FDA UDI | Class II | Active |
| Venture Heat | KB171280 L/XL | FDA UDI | Class II | Active |
| Venture Heat | KB171201 | FDA UDI | Class II | Active |
| Venture Heat | KB171290 XXL/XXXL | FDA UDI | Class II | Active |
| Venture Heat | KB172436-BLK | FDA UDI | Class II | Active |
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