Identity
- Trade Name
- CASSIE FDA UDI
- Generic Name
- Sleep disorder interpretive software, professional-only FDA UDI
- Device Name
- Cassie is a Software as a Medical Device (SaMD) that automatically analyzes, displays, and summarizes Photoplethysmogram (PPG) data collected during sleep using compatible devices. Cassie is intended for use by and by order of a healthcare professional to aid in the diagnosis of sleep disorders in adults. The Cassie output may be displayed and edited by a qualified healthcare professional. The Cassie output is not intended to be interpreted or clinical action taken without consultation of a qualified healthcare professional. FDA UDI
- Model / Reference
- 0.9.0 FDA UDI
- Description
- Cassie is a Software as a Medical Device (SaMD) that automatically analyzes, displays, and summarizes Photoplethysmogram (PPG) data collected during sleep using compatible devices. Cassie is intended for use by and by order of a healthcare professional to aid in the diagnosis of sleep disorders in adults. The Cassie output may be displayed and edited by a qualified healthcare professional. The Cassie output is not intended to be interpreted or clinical action taken without consultation of a qualified healthcare professional. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860007837036 FDA UDI
- FDA Product Code
- MNR FDA UDI
- GMDN Term
- Sleep disorder interpretive software, professional-only FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.2375 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Sleep disorder interpretive software, professional-only
Cassie by Tatch Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Tatch Inc.
Sources (1)
- FDA UDI b945b6d4-d381-4133-b332-79092dda0f18 33 fields · synced May 31, 2026