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EUDAMED last updated this device on Oct 17, 2025
5410765ElimaxLotionHSELIMAX LOTION 100ML CZ-SK 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 Czechia. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
0541076500672107030976(01)05410765006721
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
Causes serious eye irritation.
Primary placement in Czechia; available across 2 countries total.
| Country | On market since | Until |
|---|---|---|
| CzechiaPrimary placement | Jan 8, 2025 | Still on market |
| Slovakia | Jan 1, 2025 | Still on market |
BE-MF-000011797The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
IF IN EYES Rinse cautiously with water for several minutes.
IF SWALLOWED Call a POISON CENTER or doctor/physician.
CAUTION
Keep out of reach of children.
Keep away from heat/sparks/open flames/hot surfaces. No smoking.
Do not use past indicated date
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.
5410765PixieN2OGKOn the marketBECUR VORTEFRI FREEZE EXCEL5410765PixieN2OGKOn the marketELIMAX EASY POWER LOTION SPRAY5410765ElimaGreen5TOn the marketELIMAX LOTION 100ML HU5410765ElimaxLotionHSOn the marketELIMAX NATURAL LOTION5410765ElimaGreen5TOn the marketELIMAX ULTRA POWER SPRAY5410765ElimaxLotionHSOn 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.