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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 RSV / STICK RSV — 4 UDI-DI variants, IVDR (OPERON, S.A.)

MD Atlas
OPERON, S.A.

Data from EUDAMED, last updated May 23, 2026

SIMPLE RSV / STICK RSV

84295779064Y3

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: 84295779064Y3
Device name: SIMPLE RSV / STICK RSV
Device model: 9.064.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: May 21, 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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Applied filters

basicUdiUlid01JVRXS5YN4BKA7N1MW1699KB0

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

9.064.020.15.00008429577119113
9.064.020.16.00008429577007908
Simple RSV08429577003191
9.064.020.71.00008429577004792