Thermal-neb
by SOPLAST EMILIANA S.r.l. Italy EUDAMED
Ref 610
EMDN R03010380
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number805214119DMClasse2afarm6P | Date6 Feb 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Certificates
- 62182 Issued
Quality assurance EU MDR
- Notified body
- CERTIQUALITY S.r.l. 0546
- Issued
- 21 Jan 2026
- Expires
- 20 Jan 2031
Specification
- Device Name
- Dispositivi per Aerosol Che Veicolano Farmaci
- Model / Reference
- 610
- Primary DI / UDI-DI
- 08052141190081
- Basic UDI-DI
- 805214119DMClasse2afarm6P
- Direct Marketing DI
- 08052141190081
- EMDN Code
- R03010380 Aerosol therapy systems - accessories
- Device Class
- Class IIa
- Market of Registration
- Italy
Manufacturer details
- EUDAMED SRN
- IT-MF-000025628
Other devices from SOPLAST EMILIANA S.r.l.
Properties & raw data
Show properties, registry sources and raw records
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
Sources (1)
- EUDAMED f6c3c896-cf01-4baa-91f7-20b273beef76