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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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Organization name
UDI-DI code
Reference / catalog number

ViVi® HELMET²⁵ HPL — 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 HPL

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: 09009607811300
Reference / catalog number: 81130

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Manufacturer information

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

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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 HPL
UDI-DI code: 09009607811300
Basic UDI-DI: 9009607HELMET81XXXHK
Reference / catalog number: 81130
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

Certificates

Certificate health across this manufacturer's portfolio.

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