gudid
Primary ID: 5005-01/M22-N
iFlex by TCS (UDI 5005-01/M22-N)
Manufactured by THERMOPLASTIC COMFORT SYS
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for iFlex by TCS - Primary ID 5005-01/M22-N
Device Regulatory Overview
The iFlex by TCS (Model/Catalog Number: 5005-01/M22-N) is a medical device manufactured by THERMOPLASTIC COMFORT SYS. This product is indexed under FDA Product Code / Category Classification MQC within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 5005-01/M22-N
- Product Code / EMDN
- MQC
- Device Name
- iFlex by TCS is a break resistant material used in the fabrication and repair of the base plates for removable dental prosthetic appliances. This includes but is not to be limited to full and partial removable dentures, orthodontics devices, occlusal splints, and night guards.
- Database Sync Date
- 2026-08-09 09:05:42
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 iFlex by TCS?
The registered manufacturer of record for iFlex by TCS is THERMOPLASTIC COMFORT SYS.
What is the Primary UDI-DI identifier for iFlex by TCS?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 5005-01/M22-N.
What classification code is assigned to this device?
This device is registered under product classification code MQC.
Similar Classification Devices (MQC)
Other Devices by THERMOPLASTIC COMFORT SYS
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