ENT37

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

  If there is no improvement within 14 days or if symptoms worsen, stop using the product and consult a doctor. If you are pregnant or breast-feeding, suspect you may be pregnant, or are planning to have a baby, you should consult your doctor or pharmacist before using this product. For hygiene reasons and to avoid the transmission of infection, it is recommended to use one product by one person. Do not use the product after the expiration date stated on the packaging or if the packaging is damaged. Hypersensitivity (allergy) to any ingredient of the product. Do not use in the eyes or inside the ear. Do not use in the case of large mouth ulcers (painful ulceration 10-20 mm in size). Do not use in the case of severe clinical form of recurrent aphthosis (painful erosions or ulcers, partially healing, partially appearing de novo in another place, with a size of 5 to 10 mm).

Primary placement in Portugal; available across 1 country total.

Placed on the market in Portugal; per-country availability dates not published.

Trade name

not provided

UDI-DI code

D-5600954026818XR

Basic UDI-DI

B-5600954026818XR

Reference / catalog number

ENT37

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

Prodentix Wells Gel para Aftas is a medical device in the form of a coating gel used to create a protective film on the surface of the oral mucosa, which isolates the area with erosion or ulceration caused by irritants. It alleviates symptoms, including burning and soreness caused by mouth ulcers, and supports the proper renewal of the epithelium in the oral cavity.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• 15 MU03

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.