Integron (UDI IT26-1YS)
Manufactured by TERRAGENE S.A.
Device Regulatory Overview
The Integron (Model/Catalog Number: IT26-1YS) is a medical device manufactured by TERRAGENE S.A.. This product is indexed under FDA Product Code / Category Classification JOJ within international Unique Device Identification (UDI) compliance databases.
Enforcement actions are currently active for this product line.
ASP BIOTRACE Auto Read 60 Steam BI Process Challenge Device, REF 73135....
Terragene Bionova PCD (PCD222-C)...
Terragene Integron IT26-C Terragene Integron IT26-C with extender Benco Dental Chemical Integrator [5726-583] Tuttnauer (WTL198-008...
Technical Specifications
- Model Number
- IT26-1YS
- Product Code / EMDN
- JOJ
- Device Name
- Unique point Integrator Indicator for Steam sterilization processes.
- Database Sync Date
- 2026-08-09 09:07:23
Full Regulatory Attributes
🔒 Token Gated
{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
Unlock Compliance Data & Serialization Specs
Access raw JSON payloads, UDI-DI packaging hierarchies, and Notified Body IDs.
Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of Integron?
The registered manufacturer of record for Integron is TERRAGENE S.A..
What is the Primary UDI-DI identifier for Integron?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is IT26-1YS.
What classification code is assigned to this device?
This device is registered under product classification code JOJ.
Similar Classification Devices (JOJ)
Other Devices by TERRAGENE S.A.
Programmatic Export
Export this master device record as standardized JSON or CSV for compliance audits.
JSON API Endpoint