Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Contact

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

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

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

MD Atlas
OPERON, S.A.

EUDAMED last updated this device on May 21, 2025

9.081.020.47.000

84295779081Y3

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: 08429577003245
Reference / catalog number: 9.081.020.47.000

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

Manufacturer information

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

Related devices

9.23.1025.62.026 -84295779231XWOn the market 3.152.XXX.YY.ZZZB-84295773152WPFZOn the market 9.049.XXX.12.ZZZB-8429577904912DP4GOn the market 9.230.XXX.12.ZZZB-8429577923012CR23On the market 9.144.011.12.0008429577914412D9On the market

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.

Market distribution

Primary placement in Spain; available across 1 country total.

Country	On market since	Until
SpainPrimary placement	Jul 23, 2019	Still on market

Device identification

Trade name: not provided
UDI-DI code: 08429577003245
Basic UDI-DI: 84295779081Y3
Reference / catalog number: 9.081.020.47.000
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 Flu A and Flu B in independent strips 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)

W0105090699OTHER MULTIPLE PATHOGENS - 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