gudid
Primary ID: SpiroSphere Main Unit
SpiroSphere (UDI SpiroSphere Main Unit)
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 Main Unit
Device Regulatory Overview
The SpiroSphere (Model/Catalog Number: SpiroSphere Main Unit) 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 Main Unit
- Product Code / EMDN
- BTY
- Device Name
- Main Unit of 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 Main Unit.
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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