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EUDAMED last updated this device on Nov 21, 2024
B-84352323557273FNormomar® suero fisiologico bebés is an MDD-legacy medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by Laboratoire Unither. Placed on the EU market in Spain. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
D-84352323557273F8 435232 355727D-84352323557273F
DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.
European Medical Device Nomenclature — the EU product classification assigned to this device.
R060203INHALATION THERAPY HUMIDIFICATION LIQUIDSV9099VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHERQ03040299EAR IRRIGATION DEVICES - OTHERQ030103NASAL IRRIGATION SOLUTIONSQ02030299OPHTHALMOLOGY, LIQUID FLUIDS - OTHERPrimary placement in Spain; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| SpainPrimary placement | — | Still on market |
FR-MF-00000406231983Sterile
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.
B-3664353000772XTOn the marketNettoB-3250391368884VBOn the marketNormomar® suero fisiologicoB-84352323359342YOn the marketnosko® physiological serum for nasal hygieneB-5407005694435WNOn the marketnosko® physiological serum for nasal hygieneB-5407005694442WKOn the marketnosko® saline solution for inhalationB-5407005694480WTOn the marketNo 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.