Identity
- Trade Name
- Neuroradium FDA UDI
- Generic Name
- Electromyographic endotracheal tube electrode FDA UDI
- Device Name
- Laryngeal Electrode 8/9mm, 10pcs & connection cables 2pc NM FDA UDI
- Model / Reference
- NR-5001 FDA UDI
- Description
- Laryngeal Electrode 8/9mm, 10pcs & connection cables 2pc NM FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08720791373665 FDA UDI
- FDA Product Code
- ETN FDA UDI
- GMDN Term
- Electromyographic endotracheal tube electrode FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.1820 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Electromyographic endotracheal tube electrode
Neuroradium by Technomed Engineering B.V. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Electromyographic endotracheal tube electrode.
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- Invotec Single Channel Electrode — Invotec International, Inc. · Class II
- Invotec Single Channel Electrode — Invotec International, Inc. · Class II
- Nerveana® — NEUROVISION MEDICAL PRODUCTS, INC. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Technomed Engineering B.V.
Sources (1)
- FDA UDI c0fe2cb0-8454-4202-a709-3aae5b8afc55 34 fields · synced Jun 8, 2026