11

Organization name

Talkingeyes & More GmbH

SRN

DE-MF-000010488

Manufacturer status

Active

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

• CW011

  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

111883573975A

Basic UDI-DI

PP12195MDA031578

Reference / catalog number

11

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 OTS (Android) is a computer-based application with data tracking and analysis tools. The device is intended to detect the fusion capacity in conjugate eye movements. To detect the fusion capacity 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