Identity
- Trade Name
- BrainCheck Assess FDA UDI
- Generic Name
- Cognitive assessment software FDA UDI
- Device Name
- BrainCheck Assess is a digital cognitive assessment platform. FDA UDI
- Model / Reference
- 2 FDA UDI
- Description
- BrainCheck Assess is a digital cognitive assessment platform. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860011154501 FDA UDI
- FDA Product Code
- PTY FDA UDI
- GMDN Term
- Cognitive assessment software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1470 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
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Cognitive assessment software
BrainCheck Assess by Braincheck, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- T.O.V.A. — TOVA COMPANY, THE · U
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
- Braincheck, Inc.
Sources (1)
- FDA UDI 447a4690-e7bc-421e-a690-f16961184fea 33 fields · synced May 31, 2026