Nebura
Ref N01
Active
CE MDR
Valid until
18 Jun 2031
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number8437024920N017G 08437024920014 | Date2 Jul 2026 | StatusActive |
Certificates
- P000512077CRT01 Active
Quality management system EU MDR
- Certifier
- Kiwa Assurance B.V. 1912
- Issued
- 18 Jun 2026
- Expires
- 18 Jun 2031
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- N01
- Primary DI / UDI-DI
- 08437024920014
- Basic UDI-DI
- 8437024920N017G
- Direct Marketing DI
- 08437024920014
- EMDN Code
- R060101 Cold nebulisation systems
- Device Class
- Class IIa
- EU market of registration
- Spain
Manufacturer details
- EUDAMED SRN
- ES-MF-000036750
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