eudamed_udi
Primary ID: 05051700017404
Optilite® IgD Kit (UDI 05051700017404)
Manufactured by The Binding Site Group Ltd
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Optilite® IgD Kit - Primary ID 05051700017404
Device Regulatory Overview
The Optilite® IgD Kit (Model/Catalog Number: LK013.OPT) is a medical device manufactured by The Binding Site Group Ltd. This product is indexed under FDA Product Code / Category Classification W0102010103 within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- LK013.OPT
- Product Code / EMDN
- W0102010103
- Device Name
- Optilite® IgD Kit
- Database Sync Date
- 2026-08-09 16:50:31
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 Optilite® IgD Kit?
The registered manufacturer of record for Optilite® IgD Kit is The Binding Site Group Ltd.
What is the Primary UDI-DI identifier for Optilite® IgD Kit?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 05051700017404.
What classification code is assigned to this device?
This device is registered under product classification code W0102010103.
Similar Classification Devices (W0102010103)
Other Devices by The Binding Site Group Ltd
Programmatic Export
Export this master device record as standardized JSON or CSV for compliance audits.
JSON API Endpoint