CEP001C

Organization name

NEXTEC medical GmbH

SRN

DE-MF-000005572

Manufacturer status

Active

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

• CW999

  CERAPRO MED Skin Barrier Cream should not be used if you are hypersensitive to any of the ingredients.
• CW999

  Do not apply to mucous membranes such as your eyes, on your eyelids, inside your mouth/nose, auditory canal, vagina or penis, anus and deep wounds.

Primary placement in Belgium; available across 5 countries total.

Trade name

not provided

UDI-DI code

04260705080103

Basic UDI-DI

426070508MD-SKINCERA22XB

Reference / catalog number

CEP001C

Issuing entity

GS1

Risk category

Class IIa

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

CERAPRO MED Skin Barrier Cream is a substance based medical device intended to form a film-like barrier on the skin preventing loss of moisture. Additionally, it lowers the skin pH and maintains it for at least 12 hours as shown clinically. This is thought to support the skin´s inherent antimicrobial defence system. Particularly patients suffering from atopic dermatitis are likely to benefit from these effects. Atopic dermatitis is characterized by (1) dysfunction of the skin barrier leading to increased loss of water in the upper layer of the skin and hence dry skin, and (2) inflammation and elevated skin pH linked to increased colonization with pathogenic microorganisms. The skin barrier is formed by the outermost layer of the skin (stratum corneum) consisting of keratinenriched cells embedded in lipid lamellae which determine the selective permeability of the skin and are primarily composed of ceramides, cholesterol, and free fatty acids such as linoleic acid. Accordingly, impairment of skin barrier function associated with atopic dermatitis is typically linked to changes in the lipid composition of the stratum corneum.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

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

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