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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

9.028.XXX.YY.ZZZ — IVDD — General IVDD by OPERON, S.A.

MD Atlas
OPERON, S.A.

EUDAMED last updated this device on May 22, 2026

9.028.XXX.YY.ZZZ

B-84295779028XXJY

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: OPERON, S.A.
UDI-DI code: D-84295779028XXJY
Reference / catalog number: 9.028.XXX.YY.ZZZ

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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.

Market distribution

Primary placement in Spain; available across 2 countries total.

Country	On market since	Until
SpainPrimary placement	Dec 13, 2007	Still on market
EL	Oct 1, 2017	Still on market

Device identification

Trade name: not provided
UDI-DI code: D-84295779028XXJY
Basic UDI-DI: B-84295779028XXJY
Reference / catalog number: 9.028.XXX.YY.ZZZ
Issuing entity: EUDAMED

Classification

Risk category: IVDD — General
Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Single-step qualitative immunochromatographic test to aid in the diagnosis of coeliac disease by detecting antibodies directed against human tissue transglutaminase (tTG) in human blood and serum. The results of this test are intended to aid in the diagnosis of coeliac disease (CD), taking into account the data available from the patient's clinical evaluation; the test does not constitute a definitive diagnosis itself. The test is qualitative and its execution is not automated. This test is exclusively for in vitro diagnostic use. It is a professional use only product. It is not a device for near-patient testing. It is not a device self-testing.
Additional information URL: https://ifus.operon.es/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W01021699RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

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