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Bubble Humidifier (6-15 LPM), 6 PSI (410 mbars) safety valve
EUDAMEDClass IIa (EU MDR)
Ref 7900-0-25Model Salter Bubble Humidifiers
Identity
- Trade Name
- Bubble Humidifier (6-15 LPM), 6 PSI (410 mbars) safety valve EUDAMED
- Model / Reference
- Salter Bubble Humidifiers EUDAMED7900-0-25 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 20607411700051 EUDAMED
- Basic UDI-DI
- 0607411TF20015a_HumidfrVH EUDAMED
- Unit of Use DI
- 00607411700057 EUDAMED
- EMDN Code
- R060202 OXYGEN ADMINISTRATION HUMIDIFICATION SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
Yes
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Bubble Humidifier (6-15 LPM), 6 PSI (410 mbars) safety valve by Salter Labs, LLC — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0607411TF20015a_HumidfrVH | Class IIa | Active |
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Manufacturer
- Manufacturer
- Salter Labs, LLC
- EUDAMED SRN
- US-MF-000007934
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (1)
- EUDAMED edcb7078-7a00-4adf-9326-7184473e316a 61 fields · synced Oct 8, 2026