Pulmospray
by Resyca B.V.
Ref SG-47656, SG-44281Model Pulmospray MDR
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number8720865413MD-18646AB | Date3 Feb 2025 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Pulmospray MDR
- Model / Reference
- Pulmospray MDR, SG-47656, SG-44281
- Primary DI / UDI-DI
- 08720865413051, 08720865413006
- Basic UDI-DI
- 8720865413MD-18646AB
- Unit of Use DI
- 08720865413013
- EMDN Code
- R060101 Cold nebulisation systems
- Device Class
- Class IIa
- EU market of registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- NL-MF-000010950
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