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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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Organization name
UDI-DI code
Reference / catalog number

9.110.020.47.000 — IVDR Class B IVDR by OPERON, S.A.

MD Atlas
OPERON, S.A.

EUDAMED last updated this device on Aug 26, 2025

9.110.020.47.000

84295779110XH

On the marketIVDR Class B

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: OPERON, S.A.
UDI-DI code: 08429577003269
Reference / catalog number: 9.110.020.47.000

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Manufacturer information

Organization name: OPERON, S.A.
SRN: ES-MF-000004790
Manufacturer status: Active

Market distribution

Primary placement in Spain; available across 2 countries total.

Country	On market since	Until
SpainPrimary placement	Sep 13, 2019	Still on market
Portugal	May 1, 2022	Still on market

Device identification

Trade name: not provided
UDI-DI code: 08429577003269
Basic UDI-DI: 84295779110XH
Reference / catalog number: 9.110.020.47.000
Issuing entity: GS1

Classification

Risk category: IVDR Class B
Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 20
Additional product description: One-step test for the detection of RSV and Adenovirus in respiratory samples in plastic device format, in independent strips kit of 20 tests. All the necessary materials included.
Additional information URL: https://www.ifus.es/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0105099099VIROLOGY - RT & POC - OTHER

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

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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.