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EMG Surface Electrodes
EUDAMEDFDA UDIClass I (EU MDR)
Ref 13-14000-4802Model MotionWave EMG Surface Electrodes
Identity
- Trade Name
- EMG Surface Electrodes EUDAMEDElectrodes FDA UDI
- Generic Name
- Polysomnograph FDA UDI
- Device Name
- MotionWave EUDAMEDDual Snap Lead Wire, 48", 2 Pack FDA UDI
- Model / Reference
- MotionWave EMG Surface Electrodes EUDAMED13-14000-4802 EUDAMEDFDA UDI
- Description
- Dual Snap Lead Wire, 48", 2 Pack FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817377021381 EUDAMEDFDA UDI
- 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 (2)
- EUDAMED 4be6e4ba-f5a0-4e73-b5f8-305342e9501b 61 fields · synced Jul 10, 2026
- FDA UDI 8b0b059b-730b-4e82-8647-315f0aa14354 34 fields · synced May 30, 2026