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SOMNOmedics
EUDAMEDClass I (EU MDR)
Ref SEN004 Ref SEN685Model Disposable PSG BeltsRef SEN116 (Rev. B)Model CNSAC Nasal CannulaRef SEN115 (Rev. B)Ref SEN684Ref SEN116B (Rev. B)
Identity
- Trade Name
- SOMNOmedics EUDAMEDSOMNOmedics Nasal Cannulas EUDAMED
- Device Name
- ECG-PLM Electrode EUDAMEDDisposable Effort belt for SOMNOtouch RESP EUDAMEDCNSAC Nasal Cannula for PSG examinations EUDAMED
- Model / Reference
- SEN004 EUDAMEDDisposable PSG Belts EUDAMEDSEN685 EUDAMEDCNSAC Nasal Cannula EUDAMEDSEN116 (Rev. B) EUDAMEDSEN115 (Rev. B) EUDAMEDSEN684 EUDAMEDSEN116B (Rev. B) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04262356152116 EUDAMED04262356152406 EUDAMED04262356152161 EUDAMED04262356152192 EUDAMED04262356152413 EUDAMED04262356152178 EUDAMED
- Basic UDI-DI
- 426235615EC013U EUDAMED426235615SN018M EUDAMED426235615NC015T EUDAMED
- EMDN Code
- C020501 ECG ELECTRODES EUDAMEDZ12100585 POLYSOMNOGRAPHY INSTRUMENTS - CONSUMABLES EUDAMEDR03010299 OXYGEN THERAPY MASKS AND NASAL CANNULAS - 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Electrocardiographic electrode, single-use
SOMNOmedics by CNSAC Medshop GmbH — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 426235615EC013U | Class I | Active |
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Manufacturer
- Manufacturer
- CNSAC MedShop GmbH
- EUDAMED SRN
- DE-MF-000024329
Sources (6)
- EUDAMED eb64b59b-c748-4596-922e-f5c7ed8fdaeb 61 fields · synced Aug 4, 2026
- EUDAMED 53558725-8934-4689-9cda-6a36fc984a4a 61 fields · synced May 17, 2026
- EUDAMED 305d1c38-07a4-4d6e-8ea0-7e6946454654 61 fields · synced May 17, 2026
- EUDAMED 91c89718-fb90-4ce4-8d6e-c707403a77ba 61 fields · synced May 17, 2026
- EUDAMED ca2d611b-c6b2-42a8-9584-b6f2d1a33393 61 fields · synced May 17, 2026
- EUDAMED ba0379d9-c8b0-4d20-a6f1-b75a0a45d39b 61 fields · synced May 18, 2026