eudamed_udi
Primary ID: 09009607811003
ViVi® HELMET²⁵ (UDI 09009607811003)
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® HELMET²⁵ - Primary ID 09009607811003
Device Regulatory Overview
The ViVi® HELMET²⁵ (Model/Catalog Number: 81100) is a medical device manufactured by THI Total Healthcare Innovation GmbH. This product is indexed under FDA Product Code / Category Classification L0316 within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 81100
- Product Code / EMDN
- L0316
- Device Name
- ViVi® HELMET²⁵
- Database Sync Date
- 2026-08-09 18:47:59
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® HELMET²⁵?
The registered manufacturer of record for ViVi® HELMET²⁵ is THI Total Healthcare Innovation GmbH.
What is the Primary UDI-DI identifier for ViVi® HELMET²⁵?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 09009607811003.
What classification code is assigned to this device?
This device is registered under product classification code L0316.
Similar Classification Devices (L0316)
Other Devices by THI Total Healthcare Innovation GmbH
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