eudamed_udi
Primary ID: 04057155000658
iSpiro (UDI 04057155000658)
Manufactured by eResearchTechnology GmbH
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for iSpiro - Primary ID 04057155000658
Device Regulatory Overview
The iSpiro (Model/Catalog Number: 1524xx) is a medical device manufactured by eResearchTechnology GmbH. This product is indexed under FDA Product Code / Category Classification Z12159082 within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 1524xx
- Product Code / EMDN
- Z12159082
- Device Name
- iSpiro App
- Database Sync Date
- 2026-08-09 18:03:34
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 iSpiro?
The registered manufacturer of record for iSpiro is eResearchTechnology GmbH.
What is the Primary UDI-DI identifier for iSpiro?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 04057155000658.
What classification code is assigned to this device?
This device is registered under product classification code Z12159082.
Similar Classification Devices (Z12159082)
Other Devices by eResearchTechnology GmbH
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