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EUDAMED last updated this device on Apr 24, 2026
4084500CB14/CB9TLClearblue Pruebas de embarazo Ultratemprana y con Indicador de semanas 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 Spain. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
0870021652607408700216526074CH-MF-000025175V74 099371 0022(01)08700216526074
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
2 warnings recorded — scroll inside the panel to see all entries.
CW999CW999Sterile
A sterile device is supplied free of viable micro-organisms — flagged so that it is handled, stored and used to preserve that sterile state.
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.
Primary placement in Spain; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| SpainPrimary placement | — | Still on market |
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0102160302HCG - RT & POCPrimary 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 →4084500CB14QTOn the marketClearblue Prueba de embarazo Ultratemprana4084500CB14QTOn the marketClearblue Prueba de embarazo Ultratemprana digital4084500CB15QVOn the marketClearblue Schwangerschaftstest Flip & Click4084500CB11/CB11AUROn the marketClearblue Schwangerschaftstest Frühe Erkennung4084500CB14QTOn the marketClearblue Schwangerschaftstest Frühe Erkennung4084500CB14QTOn the marketCertificate health across this manufacturer's portfolio.
V74 099371 0023SupplementedV76 099371 0032IssuedV74 099371 0013SupplementedV74 099371 0022SupplementedV76 099371 0031IssuedV76 099371 0030Notified 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 →