GUDIDData
eudamed_udi Primary ID: 05415168015455

HDL Cholesterol (UDI 05415168015455)

Manufactured by Diagam S.A.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for HDL Cholesterol - Primary ID 05415168015455

Device Regulatory Overview

The HDL Cholesterol (Model/Catalog Number: HDLC-B00/COB) is a medical device manufactured by Diagam S.A.. This product is indexed under FDA Product Code / Category Classification W01010215 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
HDLC-B00/COB
Product Code / EMDN
W01010215
Device Name
HDL Cholesterol
Database Sync Date
2026-08-09 16:46:19

Full Regulatory Attributes

🔒 Token Gated
{
    "review_panel": "AN",
    "gudid_di_status": "Published",
    "sterilization_methods": ["EO", "Gamma"],
    "rx_only": true
}
                            

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Frequently Asked Questions

Who is the primary manufacturer of HDL Cholesterol?

The registered manufacturer of record for HDL Cholesterol is Diagam S.A..

What is the Primary UDI-DI identifier for HDL Cholesterol?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 05415168015455.

What classification code is assigned to this device?

This device is registered under product classification code W01010215.

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