gudid
Primary ID: SPOT.EN.GEN
SPOT (UDI SPOT.EN.GEN)
Manufactured by HEALTHY.IO LTD
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for SPOT - Primary ID SPOT.EN.GEN
Device Regulatory Overview
The SPOT (Model/Catalog Number: SPOT.EN.GEN) is a medical device manufactured by HEALTHY.IO LTD. This product is indexed under FDA Product Code / Category Classification FXN within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- SPOT.EN.GEN
- Product Code / EMDN
- FXN
- 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.
- Database Sync Date
- 2026-08-09 09:21:56
Full Regulatory Attributes
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{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
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Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of SPOT?
The registered manufacturer of record for SPOT is HEALTHY.IO LTD.
What is the Primary UDI-DI identifier for SPOT?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is SPOT.EN.GEN.
What classification code is assigned to this device?
This device is registered under product classification code FXN.
Similar Classification Devices (FXN)
Other Devices by HEALTHY.IO LTD
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