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EUDAMED last updated this device on Apr 23, 2026
697008286H162CYSeawater saline solution is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by Zhuhai Ninuo Biological Technology Co.,Ltd.. Placed on the EU market in France. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
06970082862008TYPE D17-100mL-Spray1 packaging level registered — each level carries its own UDI-DI.
06970082862008× 1 unitBase unit16970082862005× 60 units(01)06970082862008
European Medical Device Nomenclature — the EU product classification assigned to this device.
Q030103NASAL IRRIGATION SOLUTIONS1 warning recorded — scroll inside the panel to see all entries.
Do not use if you are allergic to sodium chloride
CN-MF-000023308The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
Primary placement in France; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| FrancePrimary placement | Jan 27, 2026 | 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.697008286697008286Y9On the marketOPTINOOZ KIT D'IRRIGATION DOUCHE NASALE697008286SO01KAOn the marketSeawater saline solution697008286H162CYOn the marketSINMARE Refill Pack697008286SO01KAOn the marketSTENTIL Daily nasal hygiene Isotonic 120mL697008286697008286Y9On the marketTonimer aspiratore nasale697008286NA01FZOn the market