gudid
Primary ID: SpiroSphere CT
SpiroSphere (UDI SpiroSphere 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 SpiroSphere CT
Device Regulatory Overview
The SpiroSphere (Model/Catalog Number: SpiroSphere CT) is a medical device manufactured by eResearchTechnology GmbH. This product is indexed under FDA Product Code / Category Classification BTY within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- SpiroSphere CT
- Product Code / EMDN
- BTY
- Device Name
- Diagnostic spirometer for measurement and data collection of lung function parameters
- Database Sync Date
- 2026-08-09 09:26:03
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?
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 SpiroSphere CT.
What classification code is assigned to this device?
This device is registered under product classification code BTY.
Similar Classification Devices (BTY)
Other Devices by eResearchTechnology GmbH
Programmatic Export
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JSON API Endpoint