Clearblue Test d’ovulation Digital Avancé

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.

• For in vitro diagnostic use only. Not for internal use. Do not reuse test sticks. 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 test stick foil is opened, use immediately. This product contains batteries. 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. Only use test sticks for Clearblue Advanced Digital Ovulation Test with the holder. Not for contraceptive use. Results must be read on the display and not by any lines you might see on the test stick. Do not take apart, recharge, or dispose of the batteries in fire. Do not swallow. Keep away from children. Do not dispose of electrical equipment in fire. Clomiphene citrate does not affect the tests, but may affect the length of your cycle and, therefore, when you should be testing. You may need to continue testing with a new pack. You may get misleading results if you are pregnant, have recently been pregnant, have reached the menopause, have impaired liver or kidney function, have polycystic ovarian syndrome (PCOS). Always read the manufacturer’s instructions for any medication you are taking before testing. You may get misleading results if you are taking fertility drugs containing luteinising hormone (LH) or human Chorionic Gonadotrophin, or are taking antibiotics containing tetracyclines. Clomiphene citrate does not affect the tests. If you have recently stopped using hormonal contraception your cycles may be irregular so you may wish to wait until you have had 2 cycles before testing.

  OTHER

Primary placement in Belgium; available across 2 countries total.

Trade name

Clearblue Test d’ovulation Digital Avancé

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.

08700216300056

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.

B-08700216300056

Reference / catalog number

08700216300056

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.

IVDD — Self-testing

Applicable legislation

IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

CLEARBLUE OVUL DHI 10CT BE/NL

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.

• W0102160304LH - RT & POC

• IVDD — Self-testing medical devices in EUDAMED

No certificate specifically references this device's Basic UDI-DI.

Certificate health across this manufacturer's portfolio.