GUDIDData
eudamed_udi Primary ID: 08431673431051

HbA1c-CAL (UDI 08431673431051)

Manufactured by Spinreact S.A.U.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for HbA1c-CAL - Primary ID 08431673431051

Device Regulatory Overview

The HbA1c-CAL (Model/Catalog Number: 43105) is a medical device manufactured by Spinreact S.A.U.. This product is indexed under FDA Product Code / Category Classification W0102152208 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
43105
Product Code / EMDN
W0102152208
Device Name
Glycated hemoglobin Calibrator
Database Sync Date
2026-08-09 18:50:43

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-CAL?

The registered manufacturer of record for HbA1c-CAL is Spinreact S.A.U..

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

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 08431673431051.

What classification code is assigned to this device?

This device is registered under product classification code W0102152208.

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