eudamed_udi
Primary ID: 04057155000665
SpiroSphere ECG (UDI 04057155000665)
Manufactured by eResearchTechnology GmbH
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for SpiroSphere ECG - Primary ID 04057155000665
Device Regulatory Overview
The SpiroSphere ECG (Model/Catalog Number: 151311, 151314) is a medical device manufactured by eResearchTechnology GmbH. This product is indexed under FDA Product Code / Category Classification C020599,Z12150101 within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 151311, 151314
- Product Code / EMDN
- C020599,Z12150101
- Device Name
- SpiroSphere
- Database Sync Date
- 2026-08-09 16:51:40
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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Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of SpiroSphere ECG?
The registered manufacturer of record for SpiroSphere ECG is eResearchTechnology GmbH.
What is the Primary UDI-DI identifier for SpiroSphere ECG?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 04057155000665.
What classification code is assigned to this device?
This device is registered under product classification code C020599,Z12150101.
Similar Classification Devices (C020599,Z12150101)
Other Devices by eResearchTechnology GmbH
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