GUDIDData
eudamed_udi Primary ID: 05404035101704

HbA1c Control (UDI 05404035101704)

Manufactured by Cypress Diagnostics

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for HbA1c Control - Primary ID 05404035101704

Device Regulatory Overview

The HbA1c Control (Model/Catalog Number: HT001C) is a medical device manufactured by Cypress Diagnostics. This product is indexed under FDA Product Code / Category Classification W0101050205 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
HT001C
Product Code / EMDN
W0101050205
Device Name
HbA1c Control
Database Sync Date
2026-08-09 18:01:11

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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Frequently Asked Questions

Who is the primary manufacturer of HbA1c Control?

The registered manufacturer of record for HbA1c Control is Cypress Diagnostics.

What is the Primary UDI-DI identifier for HbA1c Control?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 05404035101704.

What classification code is assigned to this device?

This device is registered under product classification code W0101050205.

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