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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

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

MD Atlas
OPERON, S.A.

EUDAMED last updated this device on Jul 17, 2025

9.134.040.15.000

84295779134XX

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: 08429577004150
Reference / catalog number: 9.134.040.15.000

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Manufacturer information

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

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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.

Critical warnings

7 warnings recorded — scroll inside the panel to see all entries.

CW265
Sample dilution buffer-1 contains sodium nitrite 13.8%
CW070
EUDAMED did not publish a description for this code.
CW076
EUDAMED did not publish a description for this code.
CW139
EUDAMED did not publish a description for this code.
CW167
EUDAMED did not publish a description for this code.
CW296
EUDAMED did not publish a description for this code.
CW374
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Spain; available across 1 country total.

Country	On market since	Until
SpainPrimary placement	May 12, 2022	Still on market

Device identification

Trade name: not provided
UDI-DI code: 08429577004150
Basic UDI-DI: 84295779134XX
Reference / catalog number: 9.134.040.15.000
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: 40
Additional product description: One-step immunochromatographic test for the detection of Streptococcus pyogenes (A) in smears, in strip format, kit of 40 tests
Additional information URL: https://www.ifus.es/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0105090103STREP. A - RT & POC

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

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Expiration date
Manufacturing date
Serial number
Software identification