← Back to catalogue
Pediatric Nasal Pressure Monitoring & Gas Sampling Cannula with 7’ (2.1 m) tube…
EUDAMEDClass I (EU MDR)
Ref 5050-7-7-25Model Salter Sleep Diagnostic CannulasRef 5049-7-7-25
by Salter Labs
Identity
- Trade Name
- Pediatric Nasal Pressure Monitoring & Gas Sampling Cannula with 7’ (2.1 m) tubes with male/female connector for gas sampling and pressure monitoring EUDAMEDPediatric Nasal Pressure Monitoring & Gas Sampling Cannula with 7’ (2.1 m) tubes with male/female connector for gas sampling and filter for pressure monitoring EUDAMED
- Model / Reference
- Salter Sleep Diagnostic Cannulas EUDAMED5050-7-7-25 EUDAMED5049-7-7-25 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10607411500401 EUDAMED10607411500364 EUDAMED
- Basic UDI-DI
- 0607411TF20010_SleepDx9V EUDAMED
- Unit of Use DI
- 00607411500404 EUDAMED00607411500367 EUDAMED
- EMDN Code
- Z12100585 POLYSOMNOGRAPHY INSTRUMENTS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class I 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
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Pediatric Nasal Pressure Monitoring & Gas Sampling Cannula with 7’ (2.1 m) tube… by Salter Labs — Class I — 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 | 0607411TF20010_SleepDx9V | Class I | 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 (2)
- EUDAMED ab35bb1b-e2d0-4e16-99b7-aba2ac677bf7 61 fields · synced Oct 6, 2026
- EUDAMED d8afa492-36e3-4757-871a-0bd3320cd325 61 fields · synced May 18, 2026