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EUDAMED last updated this device on May 27, 2026
B-04260595531594Kochsalz 0,9% Inhalat Pädia is an MDD-legacy medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by Penta Arzneimittel GmbH. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
0426059553159441089400L(01)04260595531594
European Medical Device Nomenclature — the EU product classification assigned to this device.
R060203INHALATION THERAPY HUMIDIFICATION LIQUIDS7 warnings recorded — scroll inside the panel to see all entries.
Do not use the product if single dose container is damaged.
Do not use the inhalation solution beyond the expiry date which you can find on each single dose container and on each folding box.
Consult instructions for use.
Sodium Chloride 0.9 % Inhalation Solution can also be used to dilute medicinal products for inhalation. Before this use, the directions for use of the medicinal product must be carefully read and followed.
The eye drops are filled into small plastic containers which could be swallowed by small children. Therefore, please keep the product out of the reach of children.
Primary placement in Germany; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| GermanyPrimary placement | — | Still on market |
DE-MF-000006565D1061000038Do not use for injection.
Do not use if you are allergic to any of the ingredients.
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 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.426059553MP01UD01HQOn the marketKochsalz 0,9% Inhalat Pädia426059553MP09UD01LGOn the marketKochsalz 0,9% Inhalat PädiaB-04260595531587On the marketKochsalz 0,9% Inhalat Pädia426059553MP09UD01LGOn the marketKochsalz 0,9% Inhalat Pädia (Muster)426059553MP09UD01LGOn the marketKochsalz 0,9% Inhalat Pädia (Muster)B-04260595531570On the marketNo certificate specifically references this device's Basic UDI-DI.