Identity
- Trade Name
- Minuteful for Wound EUDAMEDFDA UDI
- Generic Name
- Wound management image-analysis software FDA UDI
- Device Name
- Minuteful for Wound EUDAMEDThe 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
- MNT WND.EN.GN2 EUDAMEDFDA 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
- 17290017272716 EUDAMEDFDA UDI
- Basic UDI-DI
- 729001727250AW EUDAMED
- Direct Marketing DI
- 17290017272716 EUDAMED
- FDA Product Code
- FXN FDA UDI
- EMDN Code
- V92 MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES EUDAMED
- GMDN Term
- Wound management image-analysis software FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 878.4160 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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 by Healthy.io Ltd — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Wound management image-analysis software.
- Automated Wound Measurements — Epic Systems Corporation · Class I
- SPOT — HEALTHY.IO LTD · Class I
- Minuteful for Wound — HEALTHY.IO LTD · Class I
- Minuteful for Wound at Home — HEALTHY.IO LTD · Class I
- SPOT — HEALTHY.IO LTD · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Healthy.io Ltd
Sources (2)
- FDA UDI 29824be1-f2a5-4da7-82fa-f024aefd1a88 34 fields · synced Jul 9, 2026
- EUDAMED 65d41094-5c0a-4916-a082-60b59fc7c867 61 fields · synced Jul 9, 2026