13

Organization name

Talkingeyes & More GmbH

SRN

DE-MF-000010488

Manufacturer status

Active

1 warning recorded — scroll inside the panel to see all entries.

• CW011

  Head injury within last 4 weeks or at risk for photosensitive seizures

Primary placement in Germany; available across 1 country total.

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

Trade name

not provided

UDI-DI code

111883569138A

Basic UDI-DI

PP12195MDA031578

Reference / catalog number

13

Issuing entity

IFA

Risk category

Class I

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

VR Fusion Trainer (Platform Android) is a computer-based application with data tracking and analysis tools. The device is intended to train binocular vision (use of both eyes to see), and to decrease suppression (dimness of vision without any apparent disease of the eye). To train binocular vision using VR goggles and a handheld wireless controller at home.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• Z1399NON-SPECIFIC CONSUMABLES FOR DIAGNOSTIC INSTRUMENTS - OTHER

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification