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CapnoVue M1 Mask (Adult), thread grip, 7’ O2 line
EUDAMEDClass IIa (EU MDR)
Ref 4727TG-7-0-50Model CapnoVue Capnography Masks
by Salter Labs
Identity
- Trade Name
- CapnoVue M1 Mask (Adult), thread grip, 7’ O2 line EUDAMED
- Model / Reference
- CapnoVue Capnography Masks EUDAMED4727TG-7-0-50 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10607411971294 EUDAMED
- Basic UDI-DI
- 0607411TF20001cECO2Mask67 EUDAMED
- Unit of Use DI
- 00607411971297 EUDAMED
- EMDN Code
- R020108 RESPIRATORY GAS MONITORING AND SAMPLING CIRCUITS AND KITS 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
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
CapnoVue M1 Mask (Adult), thread grip, 7’ O2 line by Salter Labs — 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 | 0607411TF20001cECO2Mask67 | Class IIa | 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 63fc1eba-634c-4bcb-872f-027c05e08dd2 61 fields · synced Jul 9, 2026