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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

CASSETTE PREGNANCY TEST SANOVIA — IVDD — Self-testing IVDD

MD Atlas
DIAGNOSIS S.A.

EUDAMED last updated this device on May 25, 2026

CASSETTE PREGNANCY TEST SANOVIA

B-05907581250709

On the marketIVDD — Self-testing

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: DIAGNOSIS S.A.
UDI-DI code: 05907581250709
Reference / catalog number: 0020W

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View device family (Basic UDI)

Manufacturer information

Organization name: DIAGNOSIS S.A.
SRN: PL-MF-000014187
Manufacturer status: Active

Critical warnings

No critical warnings reported for this device.

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Market distribution

Primary placement in Poland; available across 1 country total.

Country	On market since	Until
PolandPrimary placement		Still on market

Device identification

Trade name: CASSETTE PREGNANCY TEST SANOVIA
UDI-DI code: 05907581250709
Basic UDI-DI: B-05907581250709
Reference / catalog number: 0020W
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: HCG RAPID TEST CASSETTE – are one-step immunoassay for the rapid, qualitative determination of human chronic gonadotropin (hCG) in urine, for the early detection of pregnancy. The test is a self-contained plastic cassette, packaged in a foil pouch that also includes a plastic dropper for adding the sample. That also includes a desiccant. TESTING TIME: 3-5 MIN. LIMIT OF DETECTION: 10 mlU/mL
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)05907581250709

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EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

W0102160302HCG - RT & POC

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

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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.