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EUDAMED last updated this device on May 29, 2026
426059553MP09SB01KQSoftBreezer® with 0.9% NaCl is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIb. Manufactured by Penta Arzneimittel GmbH. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
14260595532079590000001 packaging level registered — each level carries its own UDI-DI.
14260595532079× 1 unitBase unit44260595532070× 1 unit(01)14260595532079
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 bottle or mouthpiece is damaged.
Do not use the inhalation solution beyond the expiry date which you can find on each bottle and on each folding box.
Consult instructions for use.
Keep the medical device out of the reach of children. Do not allow children to inhale unsupervised.
Do not use if there is a risk of respiratory distress. In individual cases, temporary irritation (e.g. coughing) or a re-sensitive constriction of the bronchial tubes may occur.
DE-MF-000006565No 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.The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
Do not use if you are allergic to any of the ingredients.
In case a serious incident has occurred during the use of this medical device or as a result of its use, please report it to the manufacturer and the competent authority.
Primary placement in Germany; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| GermanyPrimary placement | — | 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.
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