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Dome Electrode
EUDAMEDFDA UDIFDA 510(k)Class I (EU MDR)
Ref B618E0Model N1
by Coapt, LLC
Identity
- Trade Name
- Dome Electrode EUDAMEDDome Electrodes FDA UDI
- Generic Name
- Analytical non-scalp cutaneous electrode FDA UDI
- Device Name
- Complete Control System Gen2 EUDAMEDNon-invasive, cutaneous electrode for use with recording and monitoring equipment of Electromyography (EMG). FDA UDI
- Model / Reference
- N1 EUDAMEDB618E0 EUDAMED1 FDA UDI
- Description
- Non-invasive, cutaneous electrode for use with recording and monitoring equipment of Electromyography (EMG). FDA UDI
Identifiers
- Primary DI / UDI-DI
- B618E0 EUDAMEDFDA UDI
- Basic UDI-DI
- ++B618N18Z EUDAMED
- Unit of Use DI
- E10001 EUDAMED
- 510(k) Number
- K190416 FDA UDI
- FDA Product Code
- GXY FDA UDI
- EMDN Code
- Y061899,Z12100480 EUDAMED
- GMDN Term
- Analytical non-scalp cutaneous electrode FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 882.1320 FDA UDI
- Market of Registration
- Sweden 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dome Electrode by Coapt, LLC — Class I — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K190416 | Class I | Active |
| EUDAMED | European Union | CE/MDR | ++B618N18Z | Class I | Active |
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Manufacturer
- Manufacturer
- Coapt, LLC
- EUDAMED SRN
- US-MF-000003759
- Authorised Representative
- Fillauer Europe AB SE-AR-000002627
Sources (3)
- EUDAMED b3e281ab-1102-40ca-92b1-4d6b627d91ce 61 fields · synced Jul 14, 2026
- FDA UDI 65fa07bc-7599-4502-b95d-5d08c249eff3 34 fields · synced May 30, 2026
- FDA 510(k) K190416 1 fields · synced May 18, 2026