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Sidestream Capnometer LoFLo
EUDAMEDClass I (EU MDR)
Ref NGA101Model Optocoupler
Identity
- Trade Name
- Sidestream Capnometer LoFLo EUDAMED
- Model / Reference
- Optocoupler EUDAMEDNGA101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250413410323 EUDAMED
- Basic UDI-DI
- 42504134anaOKU9 EUDAMED
- EMDN Code
- Z1203020299 MULTI–PARAMETER MONITORS - OTHER 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
Sidestream Capnometer LoFLo by SOMNOmedics AG — Class I — 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 | 42504134anaOKU9 | Class I | Active |
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Manufacturer
- Manufacturer
- SOMNOmedics AG
- EUDAMED SRN
- DE-MF-000006921
Sources (1)
- EUDAMED 1f128383-ad10-4422-a28f-b1345206b7cb 61 fields · synced Jun 18, 2026