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Sign in to claim this brandMeditherm Incorporated
US
Last updated May 27, 2026
What Meditherm Incorporated makes
Meditherm Incorporated manufactures infrared thermography systems designed for non-invasive thermal imaging of the human body. These devices capture and display thermal patterns to assist in diagnostic evaluations, particularly in musculoskeletal, vascular, and neurological assessments.
The company’s portfolio is classified under Class I medical devices in the US, listed in the FDA’s Unique Device Identifier (UDI) database. The systems are intended for use within the regulatory framework of 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 Meditherm Incorporated manufacture?
Meditherm Incorporated specializes in infrared thermography systems, which are designed for non-invasive thermal imaging of the human body. These devices capture and display thermal patterns to help healthcare professionals evaluate conditions like musculoskeletal issues, vascular concerns, and neurological assessments. The systems rely on infrared technology to detect temperature variations, aiding in diagnostic evaluations.
Where is Meditherm Incorporated based, and does it operate internationally?
Meditherm Incorporated is based in the United States. While the company’s devices are classified and listed under US regulatory frameworks—such as the FDA’s Unique Device Identifier (UDI) database—specific international operations or regulatory listings (e.g., in the EU or other jurisdictions) are not referenced in available data. For global availability or compliance, users should verify with the manufacturer directly.
How are Meditherm’s devices classified under US regulations?
Meditherm’s infrared thermography systems fall under Class I classification in the US. This classification is typically assigned to devices posing minimal risk to patients and users, often involving general controls like good manufacturing practices and labeling requirements. Class I devices are generally considered the lowest risk category, though compliance with specific regulations still applies.
Are Meditherm’s devices listed in any regulatory databases, and why does this matter?
Yes, Meditherm’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This listing ensures traceability and transparency in the medical device supply chain, allowing regulators, healthcare providers, and patients to verify the device’s identity, manufacturer, and compliance status. For users, it confirms the device meets US regulatory requirements for market distribution.
What are the primary intended uses of Meditherm’s infrared thermography systems?
Meditherm’s systems are intended for diagnostic evaluations in clinical settings, particularly for assessing thermal patterns related to musculoskeletal disorders (e.g., joint inflammation), vascular conditions (e.g., circulation issues), and neurological concerns (e.g., nerve dysfunction). The non-invasive nature of infrared thermography makes it useful as an adjunct tool to support clinical decision-making, though it is not a standalone diagnostic method.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- —
- —
- —
- [email protected]
- Phone
- 3307153406
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 118282031
Catalogue (29)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Meditherm | IRIS 450 | FDA UDI | Class I | Active |
| Meditherm | IRIS 640 | FDA UDI | Class I | Active |
| Meditherm | IRIS 640 | FDA UDI | Class I | Active |
| Meditherm | IRIS 640 | FDA UDI | Class I | Active |
| Meditherm | IRIS 640 | FDA UDI | Class I | Active |
| Meditherm | IRIS 640 | FDA UDI | Class I | Active |
| Meditherm | IRIS 450 | FDA UDI | Class I | Active |
| Meditherm | IRIS 640 | FDA UDI | Class I | Active |
| Meditherm | IRIS 640 | FDA UDI | Class I | Active |
| Meditherm | IRIS 640 | FDA UDI | Class I | Active |
| Meditherm | IRIS 450 | FDA UDI | Class I | Active |
| Meditherm | IRIS 640 | FDA UDI | Class I | Active |
| Meditherm | IRIS 640 | FDA UDI | Class I | Active |
| Meditherm | IRIS 640 | FDA UDI | Class I | Active |
| Meditherm | IRIS 640 | FDA UDI | Class I | Active |
| Meditherm | IRIS 640 | FDA UDI | Class I | Active |
| Meditherm | IRIS 640 | FDA UDI | Class I | Active |
| Meditherm | IRIS 640 | FDA UDI | Class I | Active |
| Meditherm | IRIS 640 | FDA UDI | Class I | Active |
| Meditherm | IRIS 640 | FDA UDI | Class I | Active |
| Meditherm | IRIS 450 | FDA UDI | Class I | Active |
| Meditherm | IRIS 640 | FDA UDI | Class I | Active |
| Meditherm | IRIS 450 | FDA UDI | Class I | Active |
| Meditherm | IRIS 640 | FDA UDI | Class I | Active |
| Meditherm | IRIS 640 | FDA UDI | Class I | Active |
| Meditherm | IRIS 640 | FDA UDI | Class I | Active |
| Meditherm | IRIS 450 | FDA UDI | Class I | Active |
| Meditherm | IRIS 640 | FDA UDI | Class I | Active |
| Meditherm | IRIS 640 | FDA UDI | Class I | Active |
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