SM03

Organization name

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

SRN

PL-MF-000003485

Manufacturer status

Active

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

• CW007

  EUDAMED did not publish a description for this code.
• CW010

  EUDAMED did not publish a description for this code.

Primary placement in Germany; available across 1 country total.

Trade name

not provided

UDI-DI code

D-59037695008888J

Basic UDI-DI

B-59037695008888J

Reference / catalog number

SM03

Issuing entity

EUDAMED

Risk category

Class IIa

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

Gel to protect the skin around the stoma is a medical device in the form of a gel, rich in ingredients that create a moisturizing and protective barrier on the skin. The product is intended for ostomy patients to protect the skin around the stoma and soothe skin irritations around the stoma. In people with a stoma, it is one of the elements of prevention of skin complications that may occur due to the use of adhesive stoma bags/plates and/or the effects of intestinal contents.

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.