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

Skyle 3 for iPad — Class I MDR by eyeV GmbH

MD Atlas
eyeV GmbH

EUDAMED last updated this device on Sep 29, 2025

Skyle 3 for iPad

417000018495Skyle3JA

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: eyeV GmbH
UDI-DI code: 04170000184959
Reference / catalog number: Skyle 3 for iPad

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: eyeV GmbH
SRN: DE-MF-000049226
Manufacturer status: Active

Critical warnings

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

CW010
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Germany; available across 1 country total.

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

Device identification

Trade name: Skyle 3 for iPad
UDI-DI code: 04170000184959
Basic UDI-DI: 417000018495Skyle3JA
Reference / catalog number: Skyle 3 for iPad
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: Skyle ist eine alternative Eingabehilfe zur Nutzung von Digitalsystemen durch Augensteuerung. Das Gerät ermöglicht die kontaktlose Steuerung digitaler Endgeräte über die Blickrichtung und eine Verweildauersteuerung. Skyle kann sowohl anstelle herkömmlicher Eingabegeräte wie Maus und Tastatur als auch ergänzend zu diesen eingesetzt werden. Es kann als Medizinprodukt zum Behinderungsausgleich bzw. zur Kompensation körperlicher Einschränkungen eingesetzt werden, um die Nutzung digitaler Systeme zu ermöglichen oder zu erleichtern.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Y210906MOUSE AND KEYBOARD EMULATORS

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

This device is not currently linked to any other device.

Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.