eudamed_udi Primary ID: 00606959427617

DreamStation CPAP Pro, ES (UDI 00606959427617)

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

Scannable UDI-DI Representation

Device Regulatory Overview

The DreamStation CPAP Pro, ES (Model/Catalog Number: ESX400S15) is a medical device manufactured by Respironics Inc.. This product is indexed under FDA Product Code / Category Classification Z12030102 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: ESX400S15
Product Code / EMDN: Z12030102
Device Name: DreamStation CPAP Pro, ES
Database Sync Date: 2026-08-09 16:30:43

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 DreamStation CPAP Pro, ES?

The registered manufacturer of record for DreamStation CPAP Pro, ES is Respironics Inc..

What is the Primary UDI-DI identifier for DreamStation CPAP Pro, ES?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 00606959427617.

What classification code is assigned to this device?

This device is registered under product classification code Z12030102.

Similar Classification Devices (Z12030102)

Other Devices by Respironics Inc.

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