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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

PRIODERM PUUR EN KRACHTIG 100ML — Class I MDR by Oystershell NV

MD Atlas
Oystershell NV

EUDAMED last updated this device on Jul 11, 2025

PRIODERM PUUR EN KRACHTIG 100ML

5410765ElimaxpurepowerXE

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Oystershell NV
UDI-DI code: 05410765003584
Reference / catalog number: 07011274

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Manufacturer information

Organization name: Oystershell NV
SRN: BE-MF-000011797
Manufacturer status: Active

Critical warnings

10 warnings recorded — scroll inside the panel to see all entries.

CW999
"For external use only. Avoid using hair dryer because the hot air from the hair dryer may increase scalp irritation. This product is only suitable for head lice (not suitable for pubic or body lice). Not suitable for children under 12 months. Do not use in case of hypersensitivity to any of the ingredients. Do not use this product if the scalp is already very irritated or damaged."
CW010
Read the leaflet carefully before treatment.
CW011
Precautions
CW032
Do not use the product after the expiry date mentioned on the package.
CW139
IGNITABILITY RISK: Keep treated hair away from fire, flames or hot objects (candles, fireplace, hair dryer, stove,..). Never smoke during use or treatment.
CW135
Keep out of sight and reach of children.
CW285
"In case of accidental ingestion or aspiration, contact a doctor or your local anti-poison center. "
CW416
In case of accidental exposure to the eyes, rinse thoroughly with water.
CW206
"In the event of signs of irritation/allergy, stop the treatment and wash your hair with your regular shampoo. Make sure you wash the product out well (also wash off skin that comes into contact with the product). In very rare cases, a mild skin irritation may occur. "
CW275
There are no data on use by pregnant or breastfeeding women. In the event of lice infestation during pregnancy or breastfeeding, consult your doctor.

Market distribution

Primary placement in Belgium; available across 1 country total.

Country	On market since	Until
BelgiumPrimary placement		Still on market

Device identification

Trade name: PRIODERM PUUR EN KRACHTIG 100ML
UDI-DI code: 05410765003584
Basic UDI-DI: 5410765ElimaxpurepowerXE
Reference / catalog number: 07011274
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: —
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

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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.