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EMG Surface Electrodes
EUDAMEDFDA UDIClass I (EU MDR)
Ref 13-14000-1002Model MotionWave EMG Surface ElectrodesRef 13-31000-0050Ref 13-41001-0050
Identity
- Trade Name
- EMG Surface Electrodes EUDAMEDElectrodes FDA UDI
- Generic Name
- Polysomnograph FDA UDI
- Device Name
- MotionWave EUDAMEDDual Snap Lead Wire, 100", 2 Pack FDA UDI
- Model / Reference
- MotionWave EMG Surface Electrodes EUDAMED13-14000-1002 EUDAMEDFDA UDI13-31000-0050 EUDAMED13-41001-0050 EUDAMED
- Description
- Dual Snap Lead Wire, 100", 2 Pack FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817377021367 EUDAMEDFDA UDI10817377023108 EUDAMED10817377022835 EUDAMED
- Basic UDI-DI
- 08173770213400008C EUDAMED
- 510(k) Number
- K020468 FDA UDI
- FDA Product Code
- GXY FDA UDI
- EMDN Code
- Z12100585 POLYSOMNOGRAPHY INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Polysomnograph FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 882.1320 FDA UDI
- Market of Registration
- Portugal EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
EMG Surface Electrodes by Dymedix Diagnostics, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Manufacturer's product page: Surface Electrodes and Snore Sensors
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 08173770213400008C | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Dymedix Diagnostics, Inc.
- EUDAMED SRN
- US-MF-000015691
- Authorised Representative
- MedEnvoy Global BV NL-AR-000024028
Sources (4)
- EUDAMED 9ee8a9a2-0d60-45e9-a5ce-aa7d5ec95953 61 fields · synced Jul 9, 2026
- EUDAMED 81c567cc-7774-4955-97ae-dbd4a843889c 61 fields · synced May 17, 2026
- EUDAMED ea0c003a-16f8-4123-9a3d-57d9eaa14535 61 fields · synced May 18, 2026
- FDA UDI 4887f81f-7478-4025-b258-d38b9a020896 34 fields · synced May 30, 2026