gudid
Primary ID: DEA
MOPTIM (UDI DEA)
Manufactured by Shenzhen CERTAINN Technology Co., Ltd.
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for MOPTIM - Primary ID DEA
Device Regulatory Overview
The MOPTIM (Model/Catalog Number: DEA) is a medical device manufactured by Shenzhen CERTAINN Technology Co., Ltd.. This product is indexed under FDA Product Code / Category Classification HLR within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- DEA
- Product Code / EMDN
- HLR
- Device Name
- The DEA is intended to do the exams related to the analysis and possible diagnosis of Dry Eye Disease(DED) through the connection of the device to you pc, and particularly. Interferometry: records a video to the patients eye to analyze quantitatively and qualitatively lipid layer of the tear film, to compare it with the related grading scale and save the value; Tear Meniscus Hight: The tear secretion of the lacrimal layer was assessed by measuring the height of the tear meniscus; NIBUT: recording a video, it allows to evaluate the stability of the tear film between the break up time in a non-invasive way and to save the value; Fluorescein BUT: records a video for the evaluation of the tear films stability, but it is done with instillation of the fluorescein in the patients eye(invasive) and without cone; Meibography: takes a picture of meibomian glands using infrared light. The device can analyze automatically the loss area of the glands to compare it with the related grading scale; Additional exams: checks for Bulbar Redness, Blepharitis, Demodex, pupillometry.All the exams that can be performed with the DEA are of fundamental importance for the ophthalmologist and the optometrist (within their respective professional skins) to study the tear film and for coaching the exams done with the classic instruments (Slit Lamp, Topography, Tonometry, etc.).
- Database Sync Date
- 2026-08-09 09:06:41
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 MOPTIM?
The registered manufacturer of record for MOPTIM is Shenzhen CERTAINN Technology Co., Ltd..
What is the Primary UDI-DI identifier for MOPTIM?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is DEA.
What classification code is assigned to this device?
This device is registered under product classification code HLR.
Similar Classification Devices (HLR)
Other Devices by Shenzhen CERTAINN Technology Co., Ltd.
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