gudid
Primary ID: 80100
ViVi Helmet (UDI 80100)
Manufactured by THI Total Healthcare Innovation GmbH
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for ViVi Helmet - Primary ID 80100
Device Regulatory Overview
The ViVi Helmet (Model/Catalog Number: 80100) is a medical device manufactured by THI Total Healthcare Innovation GmbH. This product is indexed under FDA Product Code / Category Classification FXY within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 80100
- Product Code / EMDN
- FXY
- Device Name
- Database Sync Date
- 2026-08-09 09:29:33
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 ViVi Helmet?
The registered manufacturer of record for ViVi Helmet is THI Total Healthcare Innovation GmbH.
What is the Primary UDI-DI identifier for ViVi Helmet?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 80100.
What classification code is assigned to this device?
This device is registered under product classification code FXY.
Similar Classification Devices (FXY)
Other Devices by THI Total Healthcare Innovation GmbH
Programmatic Export
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JSON API Endpoint