enforcement Primary ID: Z-2703-2026

Atellica CH Enzymatic Hemoglobin A1c (A1c_E). Material Number: 11097536. (UDI Z-2703-2026)

Manufactured by Siemens Healthcare Diagnostics, Inc.

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

Scannable UDI-DI Representation

Device Regulatory Overview

The Atellica CH Enzymatic Hemoglobin A1c (A1c_E). Material Number: 11097536. (Model/Catalog Number: Unspecified) is a medical device manufactured by Siemens Healthcare Diagnostics, Inc.. This product is indexed under FDA Product Code / Category Classification Material Number: 11097536. UDI-DI: 00630414220505. All Lot Numbers. within international Unique Device Identification (UDI) compliance databases.

ACTIVE SAFETY RECALL ALERT 3 Event(s) Found

Enforcement actions are currently active for this product line.

ID: Z-2753-2026 View Full Alert →

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ID: Z-2755-2026 View Full Alert →

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Technical Specifications

Model Number: N/A
Product Code / EMDN: Material Number: 11097536. UDI-DI: 00630414220505. All Lot Numbers.
Device Name: Atellica CH Enzymatic Hemoglobin A1c (A1c_E). Material Number: 11097536.
Database Sync Date: 2026-08-09 10:06:32

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 Atellica CH Enzymatic Hemoglobin A1c (A1c_E). Material Number: 11097536.?

The registered manufacturer of record for Atellica CH Enzymatic Hemoglobin A1c (A1c_E). Material Number: 11097536. is Siemens Healthcare Diagnostics, Inc..

What is the Primary UDI-DI identifier for Atellica CH Enzymatic Hemoglobin A1c (A1c_E). Material Number: 11097536.?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is Z-2703-2026.

What classification code is assigned to this device?

This device is registered under product classification code Material Number: 11097536. UDI-DI: 00630414220505. All Lot Numbers..

Other Devices by Siemens Healthcare Diagnostics, Inc.

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