Identity
- Trade Name
- Vitazi.ai Telehealth Portal FDA UDI
- Generic Name
- Medical image management system FDA UDI
- Device Name
- Vitazi Telehealth Portal is web-facing software used to screen patients for diabetic retinopathy (DR). The Vitazi Telehealth Portal is a software medical device. The purpose of the Vitazi Telehealth Portal is to allow licensed medical providers to review and interpret medical images. FDA UDI
- Model / Reference
- 0.0.8 FDA UDI
- Description
- Vitazi Telehealth Portal is web-facing software used to screen patients for diabetic retinopathy (DR). The Vitazi Telehealth Portal is a software medical device. The purpose of the Vitazi Telehealth Portal is to allow licensed medical providers to review and interpret medical images. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860012221608 FDA UDI
- FDA Product Code
- OUG FDA UDI
- GMDN Term
- Medical image management system FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6310 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: Medical image management system
Vitazi.ai Telehealth Portal by Vitazi.ai, Inc. — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Vitazi.ai, Inc.
Sources (1)
- FDA UDI e9c7e939-6a00-43dd-a02e-265021f28fa3 33 fields · synced Jun 8, 2026