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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Organization name
UDI-DI code
Reference / catalog number

BL28796 — Class I MDR by Omega Pharma…

MD Atlas
Omega Pharma International NV

EUDAMED last updated this device on May 21, 2026

BL28796

5400951PARPROTSHAMP2G

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Omega Pharma International NV
UDI-DI code: 05400951003429
Reference / catalog number: BL28796

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Manufacturer information

Organization name: Omega Pharma International NV
SRN: BE-MF-000007210
Manufacturer status: Active

Critical warnings

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

CW011
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.

Market distribution

Primary placement in Hungary; available across 1 country total.

Country	On market since	Until
HungaryPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 05400951003429
Basic UDI-DI: 5400951PARPROTSHAMP2G
Reference / catalog number: BL28796
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: PARANIT Protection Shampoo 200ml
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

V901001LICE ELIMINATION MECHANICAL DEVICES

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

CT299765400951PARSHAMPACZFOn the market CT321605400951PARSHAMPBCZJOn the market CT265715400951PARSHAMPBCZJOn the market CT300305400951PARTREATSHAMPC3TOn the market CT280885400951FBFORTIIBT1B3On the market

Certificates

No 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.