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EUDAMED last updated this device on May 28, 2026
4084500CB11/CB14Q8Ultra Early & Rapid Pregnancy Tests 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.
0800653045437708006530454377(01)08006530454377
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0102160302HCG - RT & POC2 warnings recorded — scroll inside the panel to see all entries.
OTHER
CH-MF-000025175V76 099371 0031The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
OTHER
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 →4084500CB15QVOn the marketTesti i shtatzënisë me treguesin e javëve4084500CB985On the marketTests de grossesse Testez et confirmezB-08700216455886On the marketUltra Early & Rapid Pregnancy Tests4084500CB11/CB14Q8On the marketUltra Early & Weeks Indicator Pregnancy Tests4084500CB14/CB9TLOn the marketUltra Early & Weeks Indicator Pregnancy Tests4084500CB14/CB9TLOn the marketCertificate health across this manufacturer's portfolio.
V76 099371 0035IssuedV76 099371 0034IssuedV74 099371 0023SupplementedV76 099371 0032IssuedV76 099371 0033IssuedV74 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.
Notified 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 →Notified 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 →Notified 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 →Notified 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 →Notified 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 →