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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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SIMPLE GDH-Toxins — 4 UDI-DI variants, IVDR (OPERON, S.A.)

MD Atlas
OPERON, S.A.

Data from EUDAMED, last updated May 23, 2026

SIMPLE GDH-Toxins

84295779065Y5

4 UDI-DI variants

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

Legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk class: IVDR Class B
Manufacturer: OPERON, S.A.

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Device characteristics

ReagentProfessional testingAnimal tissues / cells

Identity & classification

Basic UDI-DI: 84295779065Y5
Device name: SIMPLE GDH-Toxins
Device model: 9.065.XXX.YY.ZZZ
Issuing agency: GS1
Legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk class: IVDR Class B
Version date: Mar 13, 2025

Manufacturer & authorised representative

Manufacturer

Name: OPERON, S.A.
SRN: ES-MF-000004790
Country: Spain
Email: infoeudamed@operon.es
Phone: +34 976 503597

Variants by status

UDI-DI variants

4 UDI-DI variants

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Export results

Applied filters

basicUdiUlid01JP7971K8H9TDN6FGMQ3FF41E

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

9.065.020.15.00008429577007878
9.065.020.20.00008429577003054
9.065.020.16.00008429577007885
9.065.020.71.00008429577007892