Devices (same UDI-DI)
1
Certificates
1
Countries
1
Notified Bodies
1
Basic Information
- Primary DI
- D-8435232341607ZS
- Basic UDI-DI Code
- B-8435232341607ZS
- Reference
- ENT12
- 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
HIALIX® is a medical device in form of lozenges with blackcurrant flavor, which acts melting in the oral cavity, creating a protective film, which protects the mucosa of the oral cavity, throat, vocal cords and larynx from the irritating influence of external factors like bacteria or viruses. It contains natural extracts of Icelandic moss, mallow and linden, and it is rich in mucinous substances, which coat both the oral cavity and throat protecting and blocking sensory nerve endings (which are responsible for the feeling of sore throat and cough reaction).
CND Nomenclature Codes
| Code | Description |
|---|---|
| Q0399 | ENT DEVICES - OTHER |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex V | 1434-MDD-460/2020 | POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. |
Available In Countries
🇪🇸 Spain
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