gudid
Primary ID: EN8911
Titan (UDI EN8911)
Manufactured by Coloplast A/S
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Titan - Primary ID EN8911
Device Regulatory Overview
The Titan (Model/Catalog Number: EN8911) is a medical device manufactured by Coloplast A/S. This product is indexed under FDA Product Code / Category Classification FHW within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- EN8911
- Product Code / EMDN
- FHW
- Device Name
- Scrotal Zero Degree Angle Cylinder Set with Pump - Narrow
- Database Sync Date
- 2026-08-09 09:12:46
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 Titan?
The registered manufacturer of record for Titan is Coloplast A/S.
What is the Primary UDI-DI identifier for Titan?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is EN8911.
What classification code is assigned to this device?
This device is registered under product classification code FHW.
Similar Classification Devices (FHW)
Other Devices by Coloplast A/S
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