ENT09

Organization name

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

SRN

PL-MF-000003485

Manufacturer status

Active

6 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.
• CW999

  Hypersensitivity (allergy) to product ingredients.
• CW999

  Do not use after the expiration date printed on the packaging.
• CW999

  For hygiene reasons and to avoid a possible transfer of infection it is recommended to use one product for one person.
• CW999

  In the case of diseases manifested by narrowing of the respiratory tract (e.g. asthma, bronchitis, etc.) the use of MAREGAL should be consulted with a doctor.

Primary placement in Czechia; available across 1 country total.

Trade name

not provided

UDI-DI code

D-59037695019398H

Basic UDI-DI

B-59037695019398H

Reference / catalog number

ENT09

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

MAREGAL is a hypertonic solution of sea water intended for both adults and children over 3 years of age. It contains natural sea water from the Atlantic Ocean with valuable minerals. It does not contain preservatives or propellants. MAREGAL is used to improve the patency of the nose and sinuses. The natural, hypertonic sea water solution contained in the product cleans the nasal cavity and sinuses and reduces the swelling of the mucous membranes of the nose and sinuses, which leads to the patency of the nasal passages and paranasal sinuses.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• 30 MU48

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

• Q030103NASAL IRRIGATION SOLUTIONS

Certificate health across this manufacturer's portfolio.