High Flow Oxygen Therapy Kit, (1) #1600HFTLC- 25 Nasal (Adult) High Flow TLCannula, (1)- #7900 Bubble Humidifier (high flow)
Ref 7925-25-10Model Salter Bubble Humidifiers
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 | Number0607411TF20015a_HumidfrVH 10607411102063 | Date13 May 2026 | 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- Withdrawn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
- Model / Reference
- Salter Bubble Humidifiers, 7925-25-10
- Primary DI / UDI-DI
- 10607411102063
- Basic UDI-DI
- 0607411TF20015a_HumidfrVH
- Unit of Use DI
- 00607411102066
- EMDN Code
- R060202 Oxygen administration humidification systems
- Device Class
- Class IIa
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- US-MF-000007934
- Authorised representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Other devices from Salter Labs, LLC
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
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No