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Replacement 1-channel ECG sensor (2nd Part)
EUDAMEDClass IIa (EU MDR)
Ref TOS175L-BModel ECG sensor
Identity
- Trade Name
- Replacement 1-channel ECG sensor (2nd Part) EUDAMED
- Model / Reference
- ECG sensor EUDAMEDTOS175L-B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250413409235 EUDAMED
- Basic UDI-DI
- 42504134EKG-S7W EUDAMED
- EMDN Code
- Z1203020280 MULTI-PARAMETER MONITORS - HARDWARE ACCESSORIES 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Replacement 1-channel ECG sensor (2nd Part) 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 | 42504134EKG-S7W | Class IIa | Active |
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Manufacturer
- Manufacturer
- SOMNOmedics AG
- EUDAMED SRN
- DE-MF-000006921
Sources (1)
- EUDAMED 0be35c77-f2ec-481d-a06c-93e40eb641e9 61 fields · synced Aug 4, 2026