ENT37

Organization name

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

SRN

PL-MF-000003485

Manufacturer status

Active

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

• CW010

  EUDAMED did not publish a description for this code.
• CW007

  EUDAMED did not publish a description for this code.
• CW032

  EUDAMED did not publish a description for this code.
• CW999

  Hypersensitivity (allergy) to any component of the product. Do not use in the eyes or inside the ear. Do not use in case of large aphthae (painful ulceration of 10-20 mm in size). Do not use in case of severe clinical form of recurrent aphthosis (painful erosions or ulcers, partly healing, partly appearing de novo in other place, 5 to 10 mm in size). If there is no improvement within 14 days or if symptoms worsen, discontinue use and consult your 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 hygienic reasons and in order to avoid the transmission of infections, it is recommended that only one person should use the product.

Primary placement in Czechia; available across 1 country total.

Trade name

not provided

UDI-DI code

D-8595566427061F7

Basic UDI-DI

B-8595566427061F7

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

Mmedical device in the form of a coating gel used to form a protective film on the surface of the oral mucosa, which isolates the area with erosion or ulceration from irritants. It relieves symptoms including burning and soreness caused by aphthae and supports physiological renewal process of the oral epithelium.

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.