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Spot

FDA UDI

Class I (US FDA UDI)

by Healthy.io Ltd

Identity

Trade Name
SPOT FDA UDI
Generic Name
Wound management image-analysis software FDA UDI
Device Name
The SPOT device is intended to provide healthcare professionals with a tool to document, track, and monitor chronic wounds which will aid in wound care management. FDA UDI
Model / Reference
SPOT.EN.G25 FDA UDI
Description
The SPOT device is intended to provide healthcare professionals with a tool to document, track, and monitor chronic wounds which will aid in wound care management. FDA UDI

Identifiers

Primary DI / UDI-DI
17290017272556 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

Spot 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.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Healthy.io Ltd

Sources (1)

  • FDA UDI ddf3e1b0-6422-463e-874b-24688d1aa0e6 34 fields · synced May 30, 2026