Identity
- Trade Name
- Minuteful for Wound at Home FDA UDI
- Generic Name
- Wound management image-analysis software FDA UDI
- Device Name
- The Minuteful for Wound device is a comprehensive wound management system designed to assist in the management of chronic wounds. It is intended to support healthcare professionals in the clinical assessment of wounds by measuring, documenting, monitoring, and managing information relevant to the progression and treatment of chronic wounds. The device comprises Calibration Stickers, a Web Portal for healthcare professionals to review and manage wound data, and two separate smartphone applications. These applications are utilized for the collection of wound data: one for healthcare professionals and one for lay users under the guidance and supervision of healthcare professionals. FDA UDI
- Model / Reference
- WND PNT.EN.GEN FDA UDI
- Description
- The Minuteful for Wound device is a comprehensive wound management system designed to assist in the management of chronic wounds. It is intended to support healthcare professionals in the clinical assessment of wounds by measuring, documenting, monitoring, and managing information relevant to the progression and treatment of chronic wounds. The device comprises Calibration Stickers, a Web Portal for healthcare professionals to review and manage wound data, and two separate smartphone applications. These applications are utilized for the collection of wound data: one for healthcare professionals and one for lay users under the guidance and supervision of healthcare professionals. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 17290017272877 FDA UDI
- FDA Product Code
- FXN FDA UDI
- GMDN Term
- Wound management image-analysis software FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4160 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Wound management image-analysis software
Minuteful for Wound at Home by Healthy.io Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Wound management image-analysis software.
- Automated Wound Measurements — Epic Systems Corporation · Class I
- Minuteful for Wound — HEALTHY.IO LTD · Class I
- SPOT — HEALTHY.IO LTD · Class I
- Minuteful for Wound — HEALTHY.IO LTD · Class I
- SPOT — HEALTHY.IO LTD · Class I
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
- Healthy.io Ltd
Sources (1)
- FDA UDI 8a3c591f-9917-4249-b5e8-951e8fb7ea6d 34 fields · synced May 30, 2026