epoc NXS Host; Siemens Material Number (SMN): 11413518 (ROW) ; Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood in the laboratory or at the point of care. (UDI Z-0739-2025)

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 epoc NXS Host; Siemens Material Number (SMN): 11413518 (ROW) ; Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood in the laboratory or at the point of care. (Model/Catalog Number: Unspecified) is a medical device manufactured by Siemens Healthcare Diagnostics, Inc.. This product is indexed under FDA Product Code / Category Classification Siemens Material Number: 11413518; UDI-DI: 00630414605678; Software Version Number: 4.14.9. 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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Technical Specifications

Model Number: N/A
Product Code / EMDN: Siemens Material Number: 11413518; UDI-DI: 00630414605678; Software Version Number: 4.14.9.
Device Name: epoc NXS Host; Siemens Material Number (SMN): 11413518 (ROW) ; Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood in the laboratory or at the point of care.
Database Sync Date: 2026-08-09 10:06:34

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 epoc NXS Host; Siemens Material Number (SMN): 11413518 (ROW) ; Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood in the laboratory or at the point of care.?

The registered manufacturer of record for epoc NXS Host; Siemens Material Number (SMN): 11413518 (ROW) ; Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood in the laboratory or at the point of care. is Siemens Healthcare Diagnostics, Inc..

What is the Primary UDI-DI identifier for epoc NXS Host; Siemens Material Number (SMN): 11413518 (ROW) ; Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood in the laboratory or at the point of care.?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is Z-0739-2025.

What classification code is assigned to this device?

This device is registered under product classification code Siemens Material Number: 11413518; UDI-DI: 00630414605678; Software Version Number: 4.14.9..

Other Devices by Siemens Healthcare Diagnostics, Inc.

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