gudid
Primary ID: Digital Handle USB
MasterScope (UDI Digital Handle USB)
Manufactured by eResearchTechnology GmbH
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for MasterScope - Primary ID Digital Handle USB
Device Regulatory Overview
The MasterScope (Model/Catalog Number: Digital Handle USB) 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
- Digital Handle USB
- Product Code / EMDN
- BTY
- Device Name
- Spirometer handle to measure inspiratory and expiratory pulmonary function; part of MasterScope and MasterScope CT
- 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 MasterScope?
The registered manufacturer of record for MasterScope is eResearchTechnology GmbH.
What is the Primary UDI-DI identifier for MasterScope?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is Digital Handle USB.
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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