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Organization name
UDI-DI code
Reference / catalog number

PURESSENTIEL HEAD LICE TREATMENT… — Class I MDR

MD Atlas
LABORATOIRE PURESSENTIEL

EUDAMED last updated this device on May 2, 2024

PURESSENTIEL HEAD LICE TREATMENT LOTION COMPLETE TREATMENT (100 ML)

37010568POUXLOTIBV

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: LABORATOIRE PURESSENTIEL
UDI-DI code: 03401098435854
Reference / catalog number: 9843585

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Manufacturer information

Organization name: LABORATOIRE PURESSENTIEL
SRN: BE-MF-000024179
Manufacturer status: Active

Critical warnings

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

CW999
If the product becomes solid (natural and normal phenomenon), run it under hot water. Do not use for children under 3 years old, pregnant or breast-feeding women, or anyone allergic to any of the ingredients. Avoid any contact with the eyes and the mucous membranes. If in eyes, rinse thoroughly with clear water or a vegetable oil. For external use. Do not swallow. Keep out of reach of children.

Market distribution

Primary placement in Belgium; available across 2 countries total.

Country	On market since	Until
BelgiumPrimary placement		Still on market
France		Still on market

Device identification

Trade name: PURESSENTIEL HEAD LICE TREATMENT LOTION COMPLETE TREATMENT (100 ML)
UDI-DI code: 03401098435854
Basic UDI-DI: 37010568POUXLOTIBV
Reference / catalog number: 9843585
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: The medical device PURESSENTIEL Anti-lice lotion acts via its vegetable oils that obstruct the respiratory orifices of lice, larvae and nits and causes mechanical breathlessness.
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

PURESSENTIEL HEAD LICE 2 IN 1 TREATMENT SHAMPOO (150 ML)37010568POUXSHAMPIMJOn the market PURESSENTIEL HEAD LICE TREATMENT LOTION COMPLETE TREATMENT WITH COMB (100 ML)37010568POUXLOTIBVOn the market PURESSENTIEL HEAD LICE TREATMENT LOTION COMPLETE TREATMENT WITH COMB (200 ML)37010568POUXLOTIBVOn the market PURESSENTIEL® RESPIRATORY COUGH SYRUP37010568RESPIRATOIREVBMQOn the market PURESSENTIEL® RESPIRATORY DECONGESTANT NASAL SPRAY (15ml)37010568RESPIRATOIREVNNGOn 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.