ENT14

Organization name

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

SRN

PL-MF-000003485

Manufacturer status

Active

Certificate health across this manufacturer's portfolio.

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

  For hygiene reasons and to avoid the transmission of infection, it is recommended to use one product by one person. In order to maintain the properties of the product, do not manipulate the applicator. Hypersensitivity (allergy) to product ingredients. If in doubt or if symptoms persist for longer than 7 days, consult a doctor. For children over 1 year of age. The medical device should be used under adult supervision.

Primary placement in Romania; available across 1 country total.

Trade name

not provided

UDI-DI code

D-5903031283839X6

Basic UDI-DI

B-5903031283839X6

Reference / catalog number

ENT14

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

The medical device contains natural extracts of Icelandic lichen and marshmallow, rich in mucous substances, which coat the mouth, throat, larynx and vocal cords, protecting and covering the endings of the sensory nerves responsible for causing sore throat and cough reflex.

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.

• Q0399ENT DEVICES - OTHER