← Back to catalogue
EMG Surface Electrodes
EUDAMEDClass I (EU MDR)
Ref 13-40000-0050Model MotionWave EMG Surface Electrodes
Identity
- Trade Name
- EMG Surface Electrodes EUDAMED
- Device Name
- MotionWave EUDAMED
- Model / Reference
- MotionWave EMG Surface Electrodes EUDAMED13-40000-0050 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10817377021418 EUDAMED
- Basic UDI-DI
- 08173770213400008C EUDAMED
- EMDN Code
- Z12100585 POLYSOMNOGRAPHY INSTRUMENTS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Portugal 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
EMG Surface Electrodes by Dymedix Diagnostics, Inc. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Manufacturer's product page: Surface Electrodes and Snore Sensors
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 | 08173770213400008C | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Dymedix Diagnostics, Inc.
- EUDAMED SRN
- US-MF-000015691
- Authorised Representative
- MedEnvoy Global BV NL-AR-000024028
Sources (1)
- EUDAMED e9d4f02e-d013-4018-888f-294799797902 61 fields · synced Jun 19, 2026