SM04

Organization name

Gofarm Sp. z o.o. Sp. k.

SRN

PL-MF-000003485

Manufacturer status

Active

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

• CW999

  Hypersensitivity (allergy) to product ingredients. Do not use on opened unhealed wounds and on skin changes with damage of dermis. In case of fungal infections (candidiasis) or pyoderma gangrenosum before use please consult with ostomy nurse or doctor.

Primary placement in Poland; available across 4 countries total.

Trade name

not provided

UDI-DI code

D-59037695009017H

Basic UDI-DI

B-59037695009017H

Reference / catalog number

SM04

Issuing entity

EUDAMED

Risk category

Class I

Applicable legislation

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

Ostomy protective foam - a medical device with a neutral pH, intended for the skin around any type of stoma to prevent unfavorable skin changes caused by contact with intestinal contents or urine and the use of adhesives. The product creates a protective barrier on the skin that protects it against possible skin complications. Regular use of the foam ensures effective cleansing of the skin and protection against damage and irritation.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

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

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

Certificate health across this manufacturer's portfolio.