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EUDAMED last updated this device on Jul 3, 2026
4084500CB11/CB11AURRapid Detection Pregnancy Test 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 Ireland. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
0870021628788308700216287883(01)08700216287883
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0102160302HCG - RT & POC1 warning recorded — scroll inside the panel to see all entries.
OTHER
CH-MF-000025175V74 099371 0013The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
Primary 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 →4084500CB11/CB11AUROn the marketRapid Detection Pregnancy Test4084500CB11/CB11AUROn the marketRapid Detection Pregnancy Test4084500CB11/CB11AUROn the marketRychlá detekce Těhotenský test4084500CB11/CB11AUROn the marketSchwangerschaftstest Ultra Früh4084500CB14QTOn the marketSchwangerschaftstests 3 mal Gewissheit4084500CB9/CB11/CB16XNOn 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 →