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

OSC Eye Talker IG — Class I MDR by tom weber software

MD Atlas
tom weber software

EUDAMED last updated this device on Apr 6, 2025

OSC Eye Talker IG

426075543OSCETIGNM

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: tom weber software
UDI-DI code: 04260755430323
Reference / catalog number: OSCETIG

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: tom weber software
SRN: DE-MF-000044350
Manufacturer status: Active

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: OSC Eye Talker IG
UDI-DI code: 04260755430323
Basic UDI-DI: 426075543OSCETIGNM
Reference / catalog number: OSCETIG
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: https://tomwebersoftware.com/manuals/osc_eye_talker_ig_manual_1031.html
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Y214209ALPHABETIC AND SYMBOLIC COMMUNICATORS

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

OnScreenCommunicator426075543otpvV9On the market OS Umfeld Pro Vital426075543osupv84On the market OSC Eye Talker426075543OSCETIGNMOn the market OSC Light Pad426075543OLPJDOn the market OSC Mobile Pad426075543OSCMPCWOn the market

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.