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Replacement 2-channel PLM sensor for SOMNOtouch RESP
EUDAMEDClass IIa (EU MDR)
Ref TOS110-BModel PLM sensorRef TOS110-ARef TOS170-CRef TOR120Model SOMNOtouch RESP
Identity
- Trade Name
- Replacement 2-channel PLM sensor for SOMNOtouch RESP EUDAMEDReplacement 2-channel PLM sensor EUDAMEDSOMNOtouch RESP (PLM) EUDAMED
- Model / Reference
- PLM sensor EUDAMEDTOS110-B EUDAMEDTOS110-A EUDAMEDTOS170-C EUDAMEDSOMNOtouch RESP EUDAMEDTOR120 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250413409204 EUDAMED04250413499984 EUDAMED04250413405251 EUDAMED04250413405312 EUDAMED
- Basic UDI-DI
- 42504134PLMSensor6L EUDAMED42504134SOMNOtouchRESPZS EUDAMED
- EMDN Code
- Z1203020280 MULTI-PARAMETER MONITORS - HARDWARE ACCESSORIES EUDAMEDZ12100501 POLYSOMNOGRAPHS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
- Medical Purpose
- The SOMNOtouch™ RESP is a portable device for recording physiological signals, which serves the physician as a Polygraphy (PG) or Polysomnography (PSG) system to assist in the diagnosis of sleep disorders. 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
Replacement 2-channel PLM sensor for SOMNOtouch RESP by SOMNOmedics AG — 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 | 42504134PLMSensor6L | Class IIa | Active |
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Manufacturer
- Manufacturer
- SOMNOmedics AG
- EUDAMED SRN
- DE-MF-000006921
Sources (4)
- EUDAMED 48d99265-11d8-4e67-8ffa-5e21f0864488 61 fields · synced Sep 18, 2026
- EUDAMED 3618251a-bd79-4383-88a6-9d4bddcfdf81 61 fields · synced May 17, 2026
- EUDAMED ed12d1d6-d9d2-49df-b2dc-598c1d4373e3 61 fields · synced May 17, 2026
- EUDAMED 67fefd76-bb09-4063-8c7c-1675076785cd 61 fields · synced Sep 18, 2026