eudamed_udi Primary ID: D-IS02559B

HbA1c Hemoglobin Standard (UDI D-IS02559B)

Manufactured by C.P.M. COMPAGNIA PER LA MEDICINA S.R.L.

Data verified against official FDA/EUDAMED records on August 9, 2026

Scannable UDI-DI Representation

Device Regulatory Overview

The HbA1c Hemoglobin Standard (Model/Catalog Number: IS0255) is a medical device manufactured by C.P.M. COMPAGNIA PER LA MEDICINA S.R.L.. This product is indexed under FDA Product Code / Category Classification W0101050399 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: IS0255
Product Code / EMDN: W0101050399
Device Name: HbA1c Hemoglobin Standard
Database Sync Date: 2026-08-09 17:22:33

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 Hemoglobin Standard?

The registered manufacturer of record for HbA1c Hemoglobin Standard is C.P.M. COMPAGNIA PER LA MEDICINA S.R.L..

What is the Primary UDI-DI identifier for HbA1c Hemoglobin Standard?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is D-IS02559B.

What classification code is assigned to this device?

This device is registered under product classification code W0101050399.

Similar Classification Devices (W0101050399)

Other Devices by C.P.M. COMPAGNIA PER LA MEDICINA S.R.L.

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