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Clearblue Test di ovulazione Digitale Avanzato

EUDAMED

Class IVD devices for self-testing (EU MDR)

Ref 04015600769505Model ADOT

by SPD Swiss Precision Diagnostics GmbH

Identity

Trade Name
Clearblue Test di ovulazione Digitale Avanzato EUDAMED
Model / Reference
ADOT EUDAMED
04015600769505 EUDAMED

Identifiers

Primary DI / UDI-DI
04015600769505 EUDAMED
Basic UDI-DI
B-04015600769505 EUDAMED
EMDN Code
W0102160304 LH - RT & POC EUDAMED

Classification

Device Class
Class IVD devices for self-testing EUDAMED
Market of Registration
Italy EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

Yes

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

Yes

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

No

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

Yes

EUDAMED

Clearblue Test di ovulazione Digitale Avanzato by Spd Swiss Precision Diagnostics Gmbh — Class IVD devices for self-testing — IVDD — listed in EUDAMED

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

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Manufacturer

EUDAMED SRN
CH-MF-000025175
Authorised Representative
MDSS GmbH DE-AR-000005430

Sources (1)

  • EUDAMED b0b01052-e5d5-4e61-afdb-65d47c1222e6 61 fields · synced Jun 18, 2026