← Back to catalogue
High Flow Oxygen Therapy Kit, (1) #1600HFTLC-14 Nasal (Adult) High Flow TLCannu…
EUDAMEDClass IIa (EU MDR)
Ref 7914TLC-14-25Model Salter Bubble Humidifiers
by Salter Labs
Identity
- Trade Name
- High Flow Oxygen Therapy Kit, (1) #1600HFTLC-14 Nasal (Adult) High Flow TLCannula, (1) #7900 Bubble Humidifier (high flow) EUDAMED
- Model / Reference
- Salter Bubble Humidifiers EUDAMED7914TLC-14-25 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10607411893480 EUDAMED
- Basic UDI-DI
- 0607411TF20015a_HumidfrVH EUDAMED
- Unit of Use DI
- 00607411893483 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
High Flow Oxygen Therapy Kit, (1) #1600HFTLC-14 Nasal (Adult) High Flow TLCannu… by Salter Labs — Class IIa — MDR — listed in EUDAMED
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Salter Labs
- EUDAMED SRN
- US-MF-000007934
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (1)
- EUDAMED d579eb32-eecc-404d-9809-caf805255ab4 61 fields · synced Oct 6, 2026