Comfortseal*
by Trudell Medical International EUDAMED
Active
Ref 105564/105564110010
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number762860NEB1LA | Date16 Dec 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Accessory to AeroEclipse* BAN* Nebulizer
- Model / Reference
- 105564/105564110010
- Primary DI / UDI-DI
- 00762860001558
- Basic UDI-DI
- 762860NEB1LA
- EMDN Code
- R0680 Nebulisation and humidification systems - accessories not included in other classes
- Device Class
- Class I
- Market of Registration
- Portugal
Manufacturer details
- EUDAMED SRN
- CA-MF-000009860
- Authorised representative
- Emergo Europe B.V. NL-AR-000000116
Other devices from Trudell Medical International
Properties
Other properties (12)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Measuring Function: No
- Incorporates Medicinal Product: No