Devices (same UDI-DI)
1
Certificates
1
Countries
1
Notified Bodies
1
Basic Information
- Primary DI
- D-59037695019398H
- Basic UDI-DI Code
- B-59037695019398H
- Reference
- ENT09
- Device Types
- None provided
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2a
- Status
- On The Market
- Manufacturer
- Gofarm Sp. z o.o. Sp. k.
Additional 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.
CND Nomenclature Codes
| Code | Description |
|---|---|
| Q030103 | NASAL IRRIGATION SOLUTIONS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex V | 1434-MDD-331/2020 | POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. |
Available In Countries
🇨🇿 Czechia
Similar Devices
Other on-the-market devices with the same classification (Eu Md Class 2a) and regulation (EU MDD).
Coiled Tubing
Device
EU MDD
·
Eu Md Class 2a
·Liebel-Flarsheim Company, LLC ·On the market·2 countries
Sterivap HP
Device
EU MDD
·
Eu Md Class 2a
·BMT Medical Technology s.r.o.·On the market·9 countries
Sterivap
Device
EU MDD
·
Eu Md Class 2a
·BMT Medical Technology s.r.o.·On the market·9 countries
Selectomat SL
Device
EU MDD
·
Eu Md Class 2a
·BMT Medical Technology s.r.o.·On the market·2 countries
Sterivap SL
Device
EU MDD
·
Eu Md Class 2a
·BMT Medical Technology s.r.o.·On the market·7 countries
Unisteri HP
Device
EU MDD
·
Eu Md Class 2a
·BMT Medical Technology s.r.o.·On the market·8 countries