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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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ViVi® HELMET²⁵ — 4 UDI-DI variants, MDR

MD Atlas
THI Total Healthcare Innovation GmbH

Data from EUDAMED, last updated May 23, 2026

ViVi® HELMET²⁵

9009607HELMET81XXXHK

4 UDI-DI variants

MDR [Regulation (EU) 2017/745 on medical devices]Class I

Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class I
Manufacturer: THI Total Healthcare Innovation GmbH

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Device characteristics

Active device

Identity & classification

Basic UDI-DI: 9009607HELMET81XXXHK
Device name: ViVi® HELMET²⁵
Device model: ViVi® HELMET²⁵
Issuing agency: GS1
Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class I
Version date: Nov 11, 2025

Manufacturer & authorised representative

Manufacturer

Name: THI Total Healthcare Innovation GmbH
SRN: AT-MF-000044495
Country: Austria
Email: giorgio.rosati@thigmbh.at

Variants by status

UDI-DI variants

4 UDI-DI variants

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Applied filters

basicUdiUlid01K97FNVE95CXR65KEARQEN6AR

Format

Summary

29 columns included

Trade name
Basic UDI-DI
UDI-DI code
Risk category
Applicable legislation
Status
Organization name
SRN
Reference / catalog number
Additional product description
Intended medical purpose
Placed on the market (country)
Market info update date
Sterile
Single use
Contains latex
Reprocessed single-use
Direct marking
CMR substance
Endocrine disruptor
Annex XVI applicable
Sterilization
OEM applicable
EMDN codes
Last updated
Basic UDI-DI device name
Basic UDI-DI device model
Basic UDI-DI implantable
Basic UDI-DI reagent

ViVi® HELMET²⁵09009607811003
ViVi® HELMET²⁵ HPL09009607811300
ViVi® HELMET²⁵ XL09009607811010
ViVi® HELMET²⁵ XL HPL09009607811317