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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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RDx — 2 UDI-DI variants, MDR (Topcon Healthcare Solutions EMEA Oy)

MD Atlas
Topcon Healthcare Solutions EMEA Oy

Data from EUDAMED, last updated May 23, 2026

RDx

6430078740002WY

2 UDI-DI variants

MDR [Regulation (EU) 2017/745 on medical devices]Class I

Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class I
Manufacturer: Topcon Healthcare Solutions EMEA Oy

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Device characteristics

Active device

Identity & classification

Basic UDI-DI: 6430078740002WY
Device name: RDx
Issuing agency: GS1
Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class I
Special device type: refdata.special-mdr-device-type.software
Version date: Oct 21, 2021

Manufacturer & authorised representative

Manufacturer

Name: Topcon Healthcare Solutions EMEA Oy
SRN: FI-MF-000004775
Country: Finland
Email: ajansen@topcon.com
Phone: +358 40 564 9883

Variants by status

UDI-DI variants

2 UDI-DI variants

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Applied filters

basicUdiUlid01FJ1WV1ZA2DM5KY20NFDCT1M9

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

v2.706430078740098
v2.806430078740289