gudid
Primary ID: CardioSphere CT
SpiroSphere (UDI CardioSphere CT)
Manufactured by eResearchTechnology GmbH
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for SpiroSphere - Primary ID CardioSphere CT
Device Regulatory Overview
The SpiroSphere (Model/Catalog Number: CardioSphere CT) is a medical device manufactured by eResearchTechnology GmbH. This product is indexed under FDA Product Code / Category Classification DPS within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- CardioSphere CT
- Product Code / EMDN
- DPS
- Device Name
- Diagnostic device for ECG measurement and data collection
- Database Sync Date
- 2026-08-09 09:26:03
Full Regulatory Attributes
🔒 Token Gated
{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
Unlock Compliance Data & Serialization Specs
Access raw JSON payloads, UDI-DI packaging hierarchies, and Notified Body IDs.
Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of SpiroSphere?
The registered manufacturer of record for SpiroSphere is eResearchTechnology GmbH.
What is the Primary UDI-DI identifier for SpiroSphere?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is CardioSphere CT.
What classification code is assigned to this device?
This device is registered under product classification code DPS.
Similar Classification Devices (DPS)
Other Devices by eResearchTechnology GmbH
Programmatic Export
Export this master device record as standardized JSON or CSV for compliance audits.
JSON API Endpoint