- Role
- Country
- Date of registration
- Address
EUDAMED last updated this device on Sep 1, 2026
B-08700216672351Ovulation Test Advanced Digital is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — Self-testing. Manufactured by SPD Swiss Precision Diagnostics GmbH. Placed on the EU market in Ireland. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
0870021667235108700216672351(01)08700216672351
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0102160304LH - RT & POC1 warning recorded — scroll inside the panel to see all entries.
OTHER
CH-MF-000025175V1 099371 0009Primary placement in Ireland; available across 2 countries total.
| Country | On market since | Until |
|---|---|---|
| IrelandPrimary placement | — | Still on market |
| XI | — | Still on market |
Sterile
A sterile device is supplied free of viable micro-organisms — flagged so that it is handled, stored and used to preserve that sterile state.
View in glossary →Single-use device
A single-use device is intended to be used on one patient during a single procedure and then discarded — not reprocessed or reused.
View in glossary →Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
View in glossary →UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
View in glossary →IVDR risk classes
IVDR risk classes rank in-vitro diagnostic devices from lowest risk (Class A) to highest (Class D), based on the patient and public-health risk of a wrong result.
View in glossary →Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →No certificate specifically references this device's Basic UDI-DI.
4084500ADOTVCOn the marketOvulation & Rapid Pregnancy Test PackB-08700216404204On the marketOvulation Test Advanced DigitalB-08700216306539On the marketOvulation Test Advanced DigitalB-04015600566968On the marketOvulation Test Advanced DigitalB-04015600566920On the marketOvulation Test DigitalB-08700216483759On the marketCertificate health across this manufacturer's portfolio.
V76 099371 0036IssuedNotified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
V76 099371 0035IssuedNotified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
V76 099371 0034IssuedNotified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
V74 099371 0023SupplementedNotified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
V76 099371 0032IssuedNotified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
V76 099371 0033IssuedNotified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
View in glossary →