GUDIDData
eudamed_udi Primary ID: 04056839016718

HA PURE+ 7PX DBR (UDI 04056839016718)

Manufactured by Signia GmbH

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for HA PURE+ 7PX DBR - Primary ID 04056839016718

Device Regulatory Overview

The HA PURE+ 7PX DBR (Model/Catalog Number: 10945849) is a medical device manufactured by Signia GmbH. This product is indexed under FDA Product Code / Category Classification Y2145060102 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
10945849
Product Code / EMDN
Y2145060102
Device Name
RIC
Database Sync Date
2026-08-09 16:44:47

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 HA PURE+ 7PX DBR?

The registered manufacturer of record for HA PURE+ 7PX DBR is Signia GmbH.

What is the Primary UDI-DI identifier for HA PURE+ 7PX DBR?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 04056839016718.

What classification code is assigned to this device?

This device is registered under product classification code Y2145060102.

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