GUDIDData
gudid Primary ID: 81100XL

ViVi HELMET25 XL (UDI 81100XL)

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 XL - Primary ID 81100XL

Device Regulatory Overview

The ViVi HELMET25 XL (Model/Catalog Number: 81100XL) 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
81100XL
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 XL?

The registered manufacturer of record for ViVi HELMET25 XL is THI Total Healthcare Innovation GmbH.

What is the Primary UDI-DI identifier for ViVi HELMET25 XL?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 81100XL.

What classification code is assigned to this device?

This device is registered under product classification code FXZ.

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