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Organization name
UDI-DI code
Reference / catalog number

Heltiso Care Blisilico Silikonowy… — Class I MDD

MD Atlas
LABORATOIRE L'IDEAL Parisien Sp. z o.o.

EUDAMED last updated this device on May 6, 2026

Heltiso Care Blisilico Silikonowy żel na blizny 20ml tube in carton with instructions for use. Polish language version.

B-05908288961998

On the marketClass I

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: LABORATOIRE L'IDEAL Parisien Sp. z o.o.
UDI-DI code: 05908288961998
Reference / catalog number: Heltiso Care Blisilico Silikonowy żel na blizny 20ml tube in carton with instructions for use. Polish language version.

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Manufacturer information

Organization name: LABORATOIRE L'IDEAL Parisien Sp. z o.o.
SRN: PL-MF-000005402
Manufacturer status: Active

Critical warnings

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

CW999
Do not use if you are allergic to the product's ingredients If you experience itching or stinging after using the product, this may mean you are allergic to the product's ingredients; in that case, STOP USING THE PRODUCT. Avoid accidental contact with the mucous membrane of eyes and mucous membranes Do not use on damaged skin or unhealed wounds. Do not use other products directly after applying the gel to the scar. Keep away from children. Do not use after expiration date. Do not use if the packaging is damaged or tampered with before first opening The use of silicone gel can cause an MRI artifact to appear and be confused with a metallic foreign body. This warning should be given to MRI professionals. The product is intended for external use only on undamaged skin

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Market distribution

Primary placement in Poland; available across 1 country total.

Country	On market since	Until
PolandPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 05908288961998
Basic UDI-DI: B-05908288961998
Reference / catalog number: Heltiso Care Blisilico Silikonowy żel na blizny 20ml tube in carton with instructions for use. Polish language version.
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Advanced medical aid used for the treatment of previously healed scars of different origins. The gel has a smoothing and soothing effect on scar tissue, improves its appearance by softening and evening out the colour, and reducing the discoloration. The product reduces itching and the tangible tension of the skin. The product is recommended for: 1) enhancing the treatment of scars of various origins, including after: - burns, - injuries (abrasions, cuts), - surgeries (C-section), - surgical treatment - acne 2) as the scar's protective layer against rubbing and sunlight
Additional information URL: https://www.lideal.pl/
Clinical sizes: 20 MU03

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)05908288961998

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EMDN nomenclature code(s)

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

M9002PROTECTIVE DEVICES, LUBRICANTS AND SOOTHING DEVICES (SPRAYS, GELS, FLUIDS AND CREAMS)

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

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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.