Pricing Sign in

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Partners 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.

ZytoDot 2C SPEC ERBB2/CEN 17 Probe — 2 UDI-DI variants, IVDR

MD Atlas
ZytoVision GmbH

Data from EUDAMED, last updated May 23, 2026

ZytoDot 2C SPEC ERBB2/CEN 17 Probe

4250380P078RA

2 UDI-DI variants

IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]IVDR Class C

Legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk class: IVDR Class C
Manufacturer: ZytoVision GmbH

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?

Device characteristics

ReagentProfessional testingHuman tissues / cellsAnimal tissues / cells

Identity & classification

Basic UDI-DI: 4250380P078RA
Device name: ZytoDot 2C SPEC ERBB2/CEN 17 Probe
Issuing agency: GS1
Legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk class: IVDR Class C
Version date: Apr 28, 2026

Manufacturer & authorised representative

Manufacturer

Name: ZytoVision GmbH
SRN: DE-MF-000024390
Country: Germany
Email: info@zytovision.com
Phone: +49 (0)471 4832300

Variants by status

UDI-DI variants

2 UDI-DI variants

Sign in to export

Exports are reserved for signed-in users. Sign in or create an account to continue.

Email

Password

No account yet?

Export results

Applied filters

basicUdiUlid01KQ9FF495ZD6HSM1D0G958176

Format

Summary

29 columns included

Trade name
Basic UDI-DI
UDI-DI code
Risk category
Applicable legislation
Status
Organization name
SRN
Reference / catalog number
Additional product description
Intended medical purpose
Placed on the market (country)
Market info update date
Sterile
Single use
Contains latex
Reprocessed single-use
Direct marking
CMR substance
Endocrine disruptor
Annex XVI applicable
Sterilization
OEM applicable
EMDN codes
Last updated
Basic UDI-DI device name
Basic UDI-DI device model
Basic UDI-DI implantable
Basic UDI-DI reagent

C-3032-10004250380302546
C-3032-40004250380302539