GUDIDData
eudamed_udi Primary ID: 08056304454355

CAAS Qardia (UDI 08056304454355)

Manufactured by Pie Medical Imaging B.V.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for CAAS Qardia - Primary ID 08056304454355

Device Regulatory Overview

The CAAS Qardia (Model/Catalog Number: 1.0) is a medical device manufactured by Pie Medical Imaging B.V.. This product is indexed under FDA Product Code / Category Classification Z11039082 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
1.0
Product Code / EMDN
Z11039082
Device Name
CAAS Qardia 1.0
Database Sync Date
2026-08-09 17:40:56

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 CAAS Qardia?

The registered manufacturer of record for CAAS Qardia is Pie Medical Imaging B.V..

What is the Primary UDI-DI identifier for CAAS Qardia?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 08056304454355.

What classification code is assigned to this device?

This device is registered under product classification code Z11039082.

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