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EUDAMED last updated this device on Dec 10, 2024
B-5407005694435WNnosko® physiological serum for nasal hygiene is an MDD-legacy medical device registered in EUDAMED. It is classified as Class I. Manufactured by Laboratoire Unither. Placed on the EU market in Romania. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
D-5407005694435WN5 407005 694435D-5407005694435WN
DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.
European Medical Device Nomenclature — the EU product classification assigned to this device.
Q030103NASAL IRRIGATION SOLUTIONSQ02030299OPHTHALMOLOGY, LIQUID FLUIDS - OTHERFR-MF-0000040629732Primary placement in Romania; available across 2 countries total.
| Country | On market since | Until |
|---|---|---|
| RomaniaPrimary placement | — | Still on market |
| Bulgaria | — | Still on market |
Sterile
A sterile device is supplied free of viable micro-organisms — flagged so that it is handled, stored and used to preserve that sterile state.
View in glossary →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.
View in glossary →Contains latex
A "contains latex" flag warns that a device contains natural rubber latex, which can trigger allergic reactions in sensitive patients.
View in glossary →CMR substance
A CMR flag warns that a device contains a substance that is carcinogenic, mutagenic or toxic to reproduction above a defined threshold.
View in glossary →Endocrine-disrupting substance
An endocrine-disruptor flag warns that a device contains a substance with endocrine-disrupting properties above a defined threshold.
View in glossary →Primary 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 →Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →No certificate specifically references this device's Basic UDI-DI.
No certificates registered for this manufacturer.
No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.B-3250391368884VBOn the marketNormomar® suero fisiologicoB-84352323359342YOn the marketNormomar® suero fisiologico bebésB-84352323557273FOn the marketnosko® physiological serum for nasal hygieneB-5407005694442WKOn the marketnosko® saline solution for inhalationB-5407005694480WTOn the marketPharmasetB-84365385525379MOn the market