Clearblue Test de grossesse Détection Rapide

Organization name

SPD Swiss Precision Diagnostics GmbH

SRN

CH-MF-000025175

Manufacturer status

Active

1 warning recorded — scroll inside the panel to see all entries.

• CW999

  For self-testing at home. For in vitro diagnostic use only. Not for internal use. Do not reuse. Keep out of reach of children. Store between 2° – 30°C. Allow to reach room temperature for 30 minutes prior to testing if stored refrigerated. Do not use if the foil wrapper is damaged. Do not use after the ‘use by date. Once foil is opened, use immediately. Discard with normal household waste. Contains small parts. Do not eat any component of this device. If accidentally swallowed, seek medical attention. Report any injury caused by the use of this product to Clearblue and the competent authority of the member state. Always read the manufacturers’ instructions for any medication you are taking before testing. Medications containing hCG, and certain rare medical conditions, can cause false positive results. Ectopic or recent pregnancy, even if not carried to full term, can cause misleading results. If you are in or approaching the menopause you may obtain a false pregnant result even though you are not pregnant. The test should NOT be affected by hormone therapies containing Clomiphene citrate, common painkillers, alcohol, antibiotics, or the contraceptive pill. If you get any unexpected results you should discuss them with your doctor.

Primary placement in Belgium; available across 3 countries total.

Trade name

Clearblue Test de grossesse Détection Rapide

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

08700216299800

Basic UDI-DI

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.

4084500CB11/CB11AUR

Reference / catalog number

08700216299800

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

GS1

Risk category

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.

IVDR Class B

Applicable legislation

IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

CLEARBLUE PREG VIS CB11 1CT BNL

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• W0102160302HCG - RT & POC

• IVDR Class B medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.