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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

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

MD Atlas
OPERON, S.A.

EUDAMED last updated this device on May 21, 2026

9.005.XXX.YY.ZZZ

B-84295779005XKH9

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-84295779005XKH9
Reference / catalog number: 9.005.XXX.YY.ZZZ

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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	Dec 12, 2005	Still on market
Germany	Jan 1, 2025	Still on market

Device identification

Trade name: not provided
UDI-DI code: D-84295779005XKH9
Basic UDI-DI: B-84295779005XKH9
Reference / catalog number: 9.005.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: The Simple hCG s&u or Stick hCG s&U serum and urine (s&u) chromatographic immunoassay is a procedure for qualitative in vitro detection of human Chorionic Gonadotropin (hCG) hormone in serum and urine. This test has been developed to offer quick, efficient help in diagnosing pregnancy; it can be performed on the first missed day of a woman's period and provides a result in only 3-5 minutes. The result of this test is intended to support data derived from the clinical evaluation of the patient; the test does not constitute a definitive diagnosis in itself. This test is exclusively for in vitro diagnostic use. It is a product for professional use and it also may be used in a near-patient environment. It is not a self-test.
Additional information URL: https://www.operondx.com/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0102160302HCG - 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.