EUDAMED last updated this device on May 26, 2026

Paranix Spray + Ktena

5400951PARLOTIONACTK

On the marketClass I

Applicable legislation: —
Organization name: Omega Pharma International NV
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 →: 05400951005119
Reference / catalog number: CT29997

Regulatory classification unavailableThis product's Basic UDI record hasn't been published in EUDAMED yet. Classification and compliance details will appear automatically once EUDAMED publishes it.

Paranix Spray + Ktena is an EU-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by Omega Pharma International NV. Placed on the EU market in Greece. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.

Device identification

Trade name: Paranix Spray + Ktena
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 →: 05400951005119
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 →: 5400951PARLOTIONACTK
Reference / catalog number: CT29997
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 →: GS1

Classification

Risk category: Class I
Applicable legislation: —
Status: On the market

Device details

Quantity: 2
Additional product description: PARANIX Lotion Spray 100ml +Comb GR
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

Packaging levels

1 packaging level registered — each level carries its own UDI-DI.

05400951005119× 2 unitsBase unit
- 05400951003733× 2 units

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)05400951005119

UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

EMDN nomenclature code(s)

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

V901001LICE ELIMINATION MECHANICAL DEVICES

Critical warnings

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

Caution
Avoid any contact with eyes and mucous membranes (mouth, nose). In case of contact with the eyes, rinse thoroughly with clean water. If eye irritation persists, seek medical advice. Do not swallow. Do not use on irritated skin. For external use only. Consult a doctor or the anti-poison centre in case of accidental ingestion or aspiration. Do not use in case of allergy to perfume or 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. Make sure you wash out the product well. Always respect the duration of the treatment. Do not use the product under occlusion, e.g. by covering up the hair with a cap or wrapped foil. If you accidentally spill the product, wash the floor thoroughly and immediately with soap and hot water to avoid the risk of slipping.

Compliance flags

Safety

Direct marking

Regulatory

Sterilization

Lifecycle

New device

Market distribution

Primary placement in EL; available across 1 country total.

Country	On market since	Until
ELPrimary placement	Jan 1, 2000	Still on market

Paranix Spray + Ktena

Device identification

Classification

Device details

Packaging levels

UDI-PI traceability

UDI-DI DataMatrix

UDI-PI DataMatrix

EMDN nomenclature code(s)

Critical warnings

Compliance flags

Safety

Regulatory

Lifecycle

Market distribution

Related searches

Device identification

Classification

Device details

Packaging levels

Manufacturer information

UDI-PI traceability

UDI-DI DataMatrix

UDI-PI DataMatrix

EMDN nomenclature code(s)

Critical warnings

Compliance flags

Safety

Regulatory

Lifecycle

Certificates

Certificates covering this device

Related devices

Market distribution

Related searches

Manufacturer information

Certificates covering this device

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Certificates