Invotec Single Channel Electrode
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Laryngeal Surface Electrode Wrap Around EUDAMEDInvotec Single Channel Electrode FDA UDI
- Generic Name
- Electromyographic endotracheal tube electrode FDA UDI
- Device Name
- Invotec Surface Electrode EUDAMEDInvotec Single Channel Electrode, Wrap Around The Laryngeal Surface Electrode is intended to be used as a disposable, self-adhesive electrode attached to an endotracheal tube and positioned for continuous EMG monitoring of the larynx during surgical procedures. FDA UDI
- Model / Reference
- 29-80500W EUDAMED1 FDA UDI
- Description
- Invotec Single Channel Electrode, Wrap Around The Laryngeal Surface Electrode is intended to be used as a disposable, self-adhesive electrode attached to an endotracheal tube and positioned for continuous EMG monitoring of the larynx during surgical procedures. FDA UDI
Identifiers
- Catalog Number
- 29-80500W FDA UDI
- Primary DI / UDI-DI
- 00818501020034 EUDAMEDFDA UDI
- Basic UDI-DI
- 081850102LaryElectrodeFY EUDAMED
- 510(k) Number
- K122040 FDA UDI
- FDA Product Code
- ETN FDA UDI
- EMDN Code
- Q0399 ENT DEVICES - OTHER EUDAMED
- GMDN Term
- Electromyographic endotracheal tube electrode FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 874.1820 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Electromyographic endotracheal tube electrode
Invotec Single Channel Electrode by Invotec International, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Invotec International, Inc.
Sources (2)
- FDA UDI 6b0b88a6-5914-4655-b6da-507bb41f7d27 35 fields · synced Jul 29, 2026
- EUDAMED 1b4be031-248a-44b0-b8e9-e7b21bb8e3d6 61 fields · synced Jul 29, 2026