Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Contact

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

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

ViVi® HELMET²⁵ XL — Class I MDR by THI Total Healthcare…

MD Atlas
THI Total Healthcare Innovation GmbH

EUDAMED last updated this device on Nov 6, 2025

ViVi® HELMET²⁵ XL

9009607HELMET81XXXHK

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: THI Total Healthcare Innovation GmbH
UDI-DI code: 09009607811010
Reference / catalog number: 81100XL

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

Manufacturer information

Organization name: THI Total Healthcare Innovation GmbH
SRN: AT-MF-000044495
Manufacturer status: Active

Market distribution

Primary placement in Italy; available across 1 country total.

Placed on the market in Italy; per-country availability dates not published.

Device identification

Trade name: ViVi® HELMET²⁵ XL
UDI-DI code: 09009607811010
Basic UDI-DI: 9009607HELMET81XXXHK
Reference / catalog number: 81100XL
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

L0316HELMETS AND BINOCULAR GLASSES FOR SURGEONS

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

SPS - Sterile Protection Shield9009607SPSXXXAZOn the market ViVi® BATTERY HOLSTER HW - JP9009607HOLST60403WDOn the market ViVi® BATTERY PACK HW9009607BATT60402WJOn the market ViVi® FOUR-BAY CHARGER9009607CHARGERBLA6On the market ViVi® FOUR-BAY PRIO CHARGER9009607CHARGERBLA6On the market

Certificates

Certificate health across this manufacturer's portfolio.

1000302998Supplemented
Quality management systemNotified body: 0297Expiry: Apr 14, 2030