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Small Pediatric Nasal Pressure Monitoring & Gas Sampling Cannula with 7’ (2.1 m…
EUDAMEDClass I (EU MDR)
Ref 5054-7-7-25Model Salter Sleep Diagnostic Cannulas
by Salter Labs
Identity
- Trade Name
- Small Pediatric Nasal Pressure Monitoring & Gas Sampling Cannula with 7’ (2.1 m) tubes with male/female connector for gas sampling and pressure monitoring EUDAMED
- Model / Reference
- Salter Sleep Diagnostic Cannulas EUDAMED5054-7-7-25 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10607411500418 EUDAMED
- Basic UDI-DI
- 0607411TF20010_SleepDx9V EUDAMED
- Unit of Use DI
- 00607411500411 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
Small Pediatric Nasal Pressure Monitoring & Gas Sampling Cannula with 7’ (2.1 m… 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 |
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Manufacturer
- Manufacturer
- Salter Labs
- EUDAMED SRN
- US-MF-000007934
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (1)
- EUDAMED fe56a8ba-7f85-489e-b4c8-fbdc597bac63 61 fields · synced Oct 6, 2026