gudid
Primary ID: 2635
MolecuLightDX+ System (UDI 2635)
Manufactured by MolecuLight Inc
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for MolecuLightDX+ System - Primary ID 2635
Device Regulatory Overview
The MolecuLightDX+ System (Model/Catalog Number: 2635) is a medical device manufactured by MolecuLight Inc. This product is indexed under FDA Product Code / Category Classification QJF within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 2635
- Product Code / EMDN
- QJF
- Device Name
- The MolecuLightDX+ is a handheld imaging tool that allows clinicians diagnosing and treating skin wounds, at the point of care, to:(i) View and digitally record images of a wound, (ii) Measure and digitally record the size of a wound, and (iii) View and digitally record images of fluorescence emitted from a wound when exposed to an excitation light. The fluorescence image, when used in combination with clinical signs and symptoms, has been shown to increase the likelihood that clinicians can identify wounds containing bacterial loads >10^4 CFU per grams as compared to examination of clinical signs and symptoms alone. The MolecuLightDX device should not be used to rule-out the presence of bacteria in a wound.
- Database Sync Date
- 2026-08-09 09:32:43
Full Regulatory Attributes
🔒 Token Gated
{
"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 MolecuLightDX+ System?
The registered manufacturer of record for MolecuLightDX+ System is MolecuLight Inc.
What is the Primary UDI-DI identifier for MolecuLightDX+ System?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 2635.
What classification code is assigned to this device?
This device is registered under product classification code QJF.
Similar Classification Devices (QJF)
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