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Adult Nasal Pressure Monitoring & Gas Sampling Cannula with 7’ (2.1 m) tubes wi…
EUDAMEDClass I (EU MDR)
Ref 5041-7-7-25Model Salter Sleep Diagnostic Cannulas
by Salter Labs
Identity
- Trade Name
- Adult 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 EUDAMED5041-7-7-25 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10607411500357 EUDAMED
- Basic UDI-DI
- 0607411TF20010_SleepDx9V EUDAMED
- Unit of Use DI
- 00607411500350 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
Adult Nasal Pressure Monitoring & Gas Sampling Cannula with 7’ (2.1 m) tubes wi… 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 a3fc07e5-4651-4e76-bd80-180435bde577 61 fields · synced Jun 19, 2026