Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Contact

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

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

07011276 — Class I MDR by Oystershell NV

MD Atlas
Oystershell NV

EUDAMED last updated this device on Jul 11, 2025

07011276

5410765ElimaxpurepowerXE

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Oystershell NV
UDI-DI code: 05410765003614
Reference / catalog number: 07011276

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

Manufacturer information

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

Related devices

AFTIR DUO LOTION 100ML5410765ElimaxLotionHSOn the market APAISYL ANTI-POUX XPERT CIRE D’ABEILLE5410765ElimaGreen5TOn the market APAISYL ANTI-POUX XPERT CIRE D’ABEILLE5410765ElimaGreen5TOn the market APAISYL® ANTI-POUX XPERT PLUS 100ML5410765ElimaxLotionHSOn the market APAISYL® ANTI-POUX XPERT PLUS 200ML5410765ElimaxLotionHSOn 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.

Critical warnings

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

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.
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."

Market distribution

Primary placement in Denmark; available across 1 country total.

Country	On market since	Until
DenmarkPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 05410765003614
Basic UDI-DI: 5410765ElimaxpurepowerXE
Reference / catalog number: 07011276
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