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eudamed_udi Primary ID: 00630414596419

Atellica CH Alkaline Phosphatase, Concentrated (ALP_2c) (UDI 00630414596419)

Manufactured by Siemens Healthcare Diagnostics Inc.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Atellica CH Alkaline Phosphatase, Concentrated (ALP_2c) - Primary ID 00630414596419

Device Regulatory Overview

The Atellica CH Alkaline Phosphatase, Concentrated (ALP_2c) (Model/Catalog Number: 11097600) is a medical device manufactured by Siemens Healthcare Diagnostics Inc.. This product is indexed under FDA Product Code / Category Classification W01010105 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-2087-2016 View Full Alert →

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ID: Z-2058-2014 View Full Alert →

Coat-A-Count Direct Androstenedione, SMN 10381049, Catalog Number TKAN1. Siemens Healthcare Diagnostics...

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ID: Z-0459-2016 View Full Alert →

Reagent Management System (RMS) Dimension EXL with LM STM Product Usage: The Reagent Management System (RMS) is a module for use with ...

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Technical Specifications

Model Number
11097600
Product Code / EMDN
W01010105
Device Name
IVDR_67_TTN_DUB-C_B_REAG_ALP_2c
Database Sync Date
2026-08-09 17:21:39

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 Alkaline Phosphatase, Concentrated (ALP_2c)?

The registered manufacturer of record for Atellica CH Alkaline Phosphatase, Concentrated (ALP_2c) is Siemens Healthcare Diagnostics Inc..

What is the Primary UDI-DI identifier for Atellica CH Alkaline Phosphatase, Concentrated (ALP_2c)?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 00630414596419.

What classification code is assigned to this device?

This device is registered under product classification code W01010105.

Similar Classification Devices (W01010105)

Other Devices by Siemens Healthcare Diagnostics Inc.

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