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Sign in to claim this brandQr8 Health Inc
US
Last updated May 24, 2026
What Qr8 Health Inc makes
Qr8 Health Inc develops digital cognitive assessment tools designed for clinical and research use, including web-based platforms for evaluating cognitive function. Their portfolio includes software for standardized testing, such as the MSPT Web and Cognition Snapshot+, as well as analytical tools like the Chronicle Web and Cognition Chronicle variants for tracking cognitive performance over time.
The company’s products are classified as Class II medical devices under FDA regulations and are listed in the FDA’s Unique Device Identification (UDI) database. These tools are intended for use in the United States, adhering to applicable U.S. medical device compliance requirements.
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 Qr8 Health Inc manufacture?
Qr8 Health Inc specializes in developing cognitive assessment software, primarily digital tools designed for clinical and research applications. Their portfolio includes standardized cognitive testing platforms like the MSPT Web and Cognition Snapshot+, as well as analytical software such as the Chronicle Web and Cognition Chronicle variants. These tools are intended to evaluate and monitor cognitive function in structured, web-based environments.
Where is Qr8 Health Inc based, and where are their devices primarily used?
Qr8 Health Inc is based in the United States. Their devices are designed and marketed for use within the U.S., where they must comply with applicable medical device regulations, including those governing digital health tools and software.
Which regulatory registries or databases list Qr8 Health Inc’s devices?
Qr8 Health Inc’s devices are listed in the FDA’s Unique Device Identification (UDI) database. This registry ensures traceability and transparency for Class II medical devices, including their cognitive assessment software, under U.S. regulatory requirements.
How are Qr8 Health Inc’s devices classified under FDA regulations?
Qr8 Health Inc’s cognitive assessment software falls under the FDA’s Class II medical device classification. This classification is typically assigned to devices that pose moderate risk and require special controls to ensure safety and effectiveness, such as software used for clinical cognitive evaluations.
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
- 080506730
Catalogue (15)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Chronicle Web | CHR-COG-W10 | FDA UDI | Class II | Unknown |
| Cognition Snapshot v2.0 | SNP-COG-20 | FDA UDI | Class II | Unknown |
| MSPT Web v3.1.0 | MSPT-W310 | FDA UDI | Class II | Active |
| Cognition Chronicle | CHR-COG-10 | FDA UDI | Class II | Unknown |
| Cognition Snapshot+ 2.2.0 | SNP-COG-22 | FDA UDI | Class II | Active |
| Chronicle Web v2.0 | CHR-COG-W20 | FDA UDI | Class II | Active |
| Cognition Chronicle v2.0 | CHR-COG-20 | FDA UDI | Class II | Active |
| MSPT v3.0 | MSPT-30 | FDA UDI | Class II | Unknown |
| Cognition Chronicle v2.1 | CHR-COG-21 | FDA UDI | Class II | Active |
| Cognition Snapshot | SNP-COG-10 | FDA UDI | Class II | Unknown |
| Cognition Snapshot+ 2.3.0 | SNP-COG-23 | FDA UDI | Class II | Active |
| MSPT v3.1.1 | MSPT-311 | FDA UDI | Class II | Active |
| Cognition Snapshot+ v2.4 | SNP-COG-24 | FDA UDI | Class II | Active |
| MSPT Web v3.0 | MSPT-W30 | FDA UDI | Class II | Unknown |
| Cognition Snapshot+ 2.1.0 | SNP-GOG-21 | FDA UDI | Class II | Unknown |
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