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EUDAMED last updated this device on Jul 11, 2025
5410765ElimaxpurepowerXELABEL ELIMAX PURE POWER ANTI LAUS LÖSUNG 200ML is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by Oystershell NV. Placed on the EU market in Austria. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
0541076500807707030861(01)05410765008077
European Medical Device Nomenclature — the EU product classification assigned to this device.
V901001LICE ELIMINATION MECHANICAL DEVICES10 warnings recorded — scroll inside the panel to see all entries.
OTHER
Read the leaflet carefully before treatment.
Precautions
Do not use the product after the expiry date mentioned on the package.
IGNITABILITY RISK: Keep treated hair away from fire, flames or hot objects (candles, fireplace, hair dryer, stove,..). Never smoke during use or treatment.
BE-MF-000011797The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
Keep out of sight and reach of children.
"In case of accidental ingestion or aspiration, contact a doctor or your local anti-poison center. "
In case of accidental exposure to the eyes, rinse thoroughly with water.
"In the event of signs of irritation/allergy, stop the treatment and wash your hair with your regular shampoo. Make sure you wash the product out well (also wash off skin that comes into contact with the product). In very rare cases, a mild skin irritation may occur. "
There are no data on use by pregnant or breastfeeding women. In the event of lice infestation during pregnancy or breastfeeding, consult your doctor.
Primary placement in Austria; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| AustriaPrimary placement | Nov 17, 2022 | 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 →Contains latex
A "contains latex" flag warns that a device contains natural rubber latex, which can trigger allergic reactions in sensitive patients.
View in glossary →CMR substance
A CMR flag warns that a device contains a substance that is carcinogenic, mutagenic or toxic to reproduction above a defined threshold.
View in glossary →Endocrine-disrupting substance
An endocrine-disruptor flag warns that a device contains a substance with endocrine-disrupting properties above a defined threshold.
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 →MDR risk classes
MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.
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 →No certificate specifically references this device's Basic UDI-DI.
5410765ElimaxShampooCKOn the marketLABEL BEVITAMED TÄISHAMPOO 250ML5410765ElimaxShampooCKOn the marketLABEL ELIMAX PURE POWER 200ML NL-FR5410765ElimaxpurepowerXEOn the marketLABEL ELIMAX ŠAMPOON/ŠAMPŪNS/ŠAMPŪNAS 100ML EST-LAT-LIT5410765ElimaxShampooCKOn the marketLABEL ELIMAX SHAMPOO 100ML CZ-SK5410765ElimaxShampooCKOn the marketLABEL ELIMAX SHAMPOO 100ML HU5410765ElimaxShampooCKOn the marketNo certificates registered for this manufacturer.
No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.