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EUDAMED last updated this device on Dec 4, 2024
7332343200127JAlvita Spray Nasal Hipertónico is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by Aurena Laboratories AB. Placed on the EU market in Spain. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
07332343300763301427SE-MF-000002890Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →(01)07332343300763
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
9 warnings recorded — scroll inside the panel to see all entries.
CW999CW999CW999CW999CW268CW157CW139CW999CW999Sterile
A sterile device is supplied free of viable micro-organisms — flagged so that it is handled, stored and used to preserve that sterile state.
Single-use device
A single-use device is intended to be used on one patient during a single procedure and then discarded — not reprocessed or reused.
Contains latex
A "contains latex" flag warns that a device contains natural rubber latex, which can trigger allergic reactions in sensitive patients.
CMR substance
A CMR flag warns that a device contains a substance that is carcinogenic, mutagenic or toxic to reproduction above a defined threshold.
Endocrine-disrupting substance
An endocrine-disruptor flag warns that a device contains a substance with endocrine-disrupting properties above a defined threshold.
Primary placement in Spain; available across 3 countries total.
| Country | On market since | Until |
|---|---|---|
| SpainPrimary placement | Nov 26, 2024 | Still on market |
| Italy | Nov 26, 2024 | Still on market |
| Portugal | Nov 26, 2024 | Still on market |
European Medical Device Nomenclature — the EU product classification assigned to this device.
Q030103NASAL IRRIGATION SOLUTIONSPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
View in glossary →UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
View in glossary →MDR risk classes
MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.
View in glossary →Certificate health across this manufacturer's portfolio.
28620131862IssuedNotified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
View in glossary →7332343200067POn the marketAlvita Spray Auriculaire Nettoyant7332343200097VOn the marketAlvita Spray Nasal Água do Mar7332343200067POn the marketApotekets Næsedouche Saltvand Ekstra7332343200127JOn the marketApotekets Næsedouche Saltvand Neutral7332343200067POn the marketApotekets Ørespray Saltvand Neutral7332343200097VOn the market