GUDIDData
gudid Primary ID: 81100

ViVi HELMET25 (UDI 81100)

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 81100

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 FXZ within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
81100
Product Code / EMDN
FXZ
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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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 81100.

What classification code is assigned to this device?

This device is registered under product classification code FXZ.

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