SoftBreezer® with 3% NaCl
by Penta Arzneimittel GmbH Germany EUDAMED
Ref 41113900Model Inhalation Solution EMDN R060203
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number426059553MP28SB01L7 | Date29 May 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Sodium Chloride 3% Inhalation Solution
- Model / Reference
- Inhalation Solution, 41113900
- Primary DI / UDI-DI
- 14260595532086
- Basic UDI-DI
- 426059553MP28SB01L7
- EMDN Code
- R060203 Inhalation therapy humidification liquids
- Device Class
- Class IIb
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- DE-MF-000006565
Other devices from Penta Arzneimittel GmbH
Properties & raw data
Show properties, registry sources and raw records
Other properties (12)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
Sources (1)
- EUDAMED ae4a8378-317c-4252-9269-d1fe6898a3c5