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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

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

MD Atlas
OPERON, S.A.

EUDAMED last updated this device on May 21, 2025

9.080.020.46.000

84295779080XZ

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: 08429577003214
Reference / catalog number: 9.080.020.46.000

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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	Jul 19, 2019	Still on market
Portugal	Mar 1, 2021	Still on market

Device identification

Trade name: not provided
UDI-DI code: 08429577003214
Basic UDI-DI: 84295779080XZ
Reference / catalog number: 9.080.020.46.000
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 Flu A and Flu B in respiratory samples in plastic device format, kit of 20 tests. All the necessary materials included.
Additional information URL: https://www.ifus.operon.es/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0105099004INFLUENZA A AND /OR B - RT & POC

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.