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EUDAMED last updated this device on May 27, 2026
5400951PARPROTSHAMP2GParanix Champô Proteção Contra Piolhos is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by Omega Pharma International NV. Placed on the EU market in Portugal. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
054009510034431000017169 BL(01)05400951003443
European Medical Device Nomenclature — the EU product classification assigned to this device.
V901001LICE ELIMINATION MECHANICAL DEVICES1 warning recorded — scroll inside the panel to see all entries.
For use on adults and children as of 2 years old Caution Avoid contact with eyes and mucous membranes. In case of eye contact, rinse thoroughly with water. If eyes irritation persist, seek medical advice. Do not swallow. Consult a doctor or the anti-poison centre in case of accidental ingestion. Do not use on irritated skin. Do not use in case of allergy to perfume or to any of the listed ingredients. In the event of a rash breaking out, an irritation, or hyper-sensitivity stop the treatment immediately, and wash your hair with your regular shampoo. Keep out of reach of children. FOR EXTERNAL USE ONLY. This product is only suitable for head lice (not pubic or body lice). Pregnancy and breastfeeding There is no known contraindication for pregnant and breastfeeding women to use Paranix Treatment Shampoo. However, it is recommended to always seek the advice of your doctor or pharmacist before using a product when pregnant or breastfeeding. Possible side effects Itching and irritation around the eyes. Flaking of the scalp. Contact irritation and redness of the scalp, ears or neck.
BE-MF-000007210The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
Primary placement in Portugal; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| PortugalPrimary placement | — | 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.
5400951PARTREATSHAMPC3TOn the marketParanit Sprej + Hřeben5400951PARLOTIONACTKOn the marketParanitPršilo + Glavnik5400951PARLOTIONACTKOn the marketParanix Express Spray + Pente5400951PAREXPLOTIONCZ7On the marketParanix Express Loção + Pente5400951PAREXPLOTIONCZ7On the marketParanix Express ΣΑΜΠΟΥΑΝ + Ktena5400951PARSHAMPBCZJOn the marketCertificate health across this manufacturer's portfolio.
20311GB448260506SupplementedNotified 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 →