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EUDAMED last updated this device on Jun 29, 2026
4084500CB9/CB11/CB16XNSchwangerschaftstests 3 mal Gewissheit is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class B. Manufactured by SPD Swiss Precision Diagnostics GmbH. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
0800653045419308006530454193(01)08006530454193
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0102160302HCG - RT & POC3 warnings recorded — scroll inside the panel to see all entries.
CW999CW999CH-MF-000025175V76 099371 0032The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
CW999Primary placement in Germany; available across 2 countries total.
| Country | On market since | Until |
|---|---|---|
| GermanyPrimary placement | — | Still on market |
| Austria | — | 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 →4084500CB11/CB11AUROn the marketFertilitätsmonitor AdvancedB-04015600997205On the marketSchwangerschaftstest Ultra Früh4084500CB14QTOn the marketTěhotenský test s ukazatelem týdnů4084500CB985On the marketTest di gravidanza con Indicatore delle Settimane4084500CB985On the marketTest di gravidanza Rilevazione Precoce e Rapida4084500CB11/CB14Q8On the marketCertificate health across this manufacturer's portfolio.
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.
V74 099371 0013SupplementedNotified 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 0022SupplementedNotified 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 0031IssuedNotified 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 →