gudid
Primary ID: 1.0
Brainlab Elements BOLD MRI Mapping (UDI 1.0)
Manufactured by Brainlab SE
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Brainlab Elements BOLD MRI Mapping - Primary ID 1.0
Device Regulatory Overview
The Brainlab Elements BOLD MRI Mapping (Model/Catalog Number: 1.0) is a medical device manufactured by Brainlab SE. This product is indexed under FDA Product Code / Category Classification QIH within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 1.0
- Product Code / EMDN
- QIH
- Device Name
- Database Sync Date
- 2026-08-09 09:26:08
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 Brainlab Elements BOLD MRI Mapping?
The registered manufacturer of record for Brainlab Elements BOLD MRI Mapping is Brainlab SE.
What is the Primary UDI-DI identifier for Brainlab Elements BOLD MRI Mapping?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 1.0.
What classification code is assigned to this device?
This device is registered under product classification code QIH.
Similar Classification Devices (QIH)
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