GUDIDData
gudid Primary ID: 81130XL

ViVi HELMET25 XL HPL (UDI 81130XL)

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 HPL - Primary ID 81130XL

Device Regulatory Overview

The ViVi HELMET25 XL HPL (Model/Catalog Number: 81130XL) 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
81130XL
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 HPL?

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

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

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 81130XL.

What classification code is assigned to this device?

This device is registered under product classification code FXZ.

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