Thermal Imaging Module

Adds thermal imaging capabilities to the MolecuLightDX+ device to quantify skin temperature changes at the point-of-care.

Registry build 21.09.26
4manufacturers in China registered for this device type
1catalogue number

Who Else Makes It

Concentrated in Jiangsu (2), Guangdong (2). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code FXN
Manufacturer City Province Registered as Device types
Dongguan Hosscom Plastic Technology Co., Ltd. Dongguan Guangdong Contract manufacturer 1
Suzhou Texnet Suzhou Jiangsu Contract manufacturer 47
Changzhou Major Medical Products Co., Ltd. Changzhou Jiangsu Contract manufacturer 31
Guangdong Tidakang Medical Technology Co., Ltd. Zhongshan Guangdong Manufacturer 12

Record

Regulatory record for Thermal Imaging Module
Listed by Moleculight Inc., Canada
FDA product code FXN
Device type Tape, Camera, Surgical
Device class Class 1
Regulation 21 CFR 878.4160
Establishment Specification developer, Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2026-07-08

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Label carries manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for Thermal Imaging Module
Catalogue number Size Status
2640 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Minuteful for Wound Healthy.io Ltd. 2
Spot Healthy.io Ltd. 2
SnapshotGLO Kent Imaging Inc 1
Swift Vision Swift Medical 1
Healogics Photo+ Swift Medical 1
MolecuLightDX+ Thermal Eco Clip Moleculight Inc. 1
Tissue Analytics Net Health Systems, Inc. 1
eKare inSight E-Kare Inc. 1
Minuteful for Wound at Home Healthy.io Ltd. 1
PointClickCare Skin and Wound Swift Medical 1
Medline NE1® WMS Swift Medical 1
Automated Wound Measurements Epic Systems Corporation 1

Showing 12 of 16. All products under Tape, Camera, Surgical

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer