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

19.10.2.1 — Class IIa MDR by Talkingeyes & More GmbH

MD Atlas
Talkingeyes & More GmbH

EUDAMED last updated this device on Dec 7, 2021

19.10.2.1

PP12195Z139911

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Talkingeyes & More GmbH
UDI-DI code: 111788598865
Reference / catalog number: 19.10.2.1

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: Talkingeyes & More GmbH
SRN: DE-MF-000010488
Manufacturer status: Active

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement	Feb 5, 2019	Dec 26, 2023

Device identification

Trade name: not provided
UDI-DI code: 111788598865
Basic UDI-DI: PP12195Z139911
Reference / catalog number: 19.10.2.1
Issuing entity: IFA

Classification

Risk category: Class IIa
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Cloudbasierte Software zur Diagnosestellung in der Augenheilkunde
Additional information URL: https://www.talkingeyes.de/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z1399NON-SPECIFIC CONSUMABLES FOR DIAGNOSTIC INSTRUMENTS - OTHER

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

1PP12195MDA031578On the market VR Fusion TrainerPP12195Z1341On the market 11PP12195MDA031578On the market 20240516PP12195MDA031578On the market 12PP12195MDA031578On 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.