Identity
- Trade Name
- Technomed Europe FDA UDI
- Generic Name
- Electromyographic needle electrode, single-use FDA UDI
- Device Name
- Disposable Subdermal Needle Electrode corkscrew, 1.5m wire, 4x6 colors, 24pcs with Protection Cap FDA UDI
- Model / Reference
- TE/S50715-004-C FDA UDI
- Description
- Disposable Subdermal Needle Electrode corkscrew, 1.5m wire, 4x6 colors, 24pcs with Protection Cap FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08720791375379 FDA UDI
- 510(k) Number
- K241045 FDA UDI
- FDA Product Code
- IKT FDA UDIGXZ FDA UDI
- GMDN Term
- Electromyographic needle electrode, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.1385 FDA UDI882.1350 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
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 1.5 Meter FDA UDIOuter Diameter — 0.60 Millimeter FDA UDINeedle Gauge — 23 Gauge FDA UDI
Category: Electromyographic needle electrode, single-use
A safe and effective diagnostic tool for detecting bioelectrical signal activity in muscle or nerve tissue. This single-use device is designed to be inserted percutaneously into the body, allowing for precise measurement of electrical signals.
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Also classified as Electromyographic needle electrode, single-use.
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Cleared under the same submission
K241045 also covers:
- Technomed Europe — Technomed Engineering B.V.
- Technomed Europe — Technomed Engineering B.V.
- Technomed Europe — Technomed Engineering B.V.
- Technomed Europe — Technomed Engineering B.V.
- Technomed Europe — Technomed Engineering B.V.
- Technomed Europe — Technomed Engineering B.V.
- Technomed Europe — Technomed Engineering B.V.
- Technomed Europe — Technomed Engineering B.V.
- Technomed Europe — Technomed Engineering B.V.
- Technomed Europe — Technomed Engineering B.V.
- Technomed Europe — Technomed Engineering B.V.
- Technomed Europe — Technomed Engineering B.V.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Technomed Engineering B.V.
Sources (1)
- FDA UDI 2ebd5f6a-7cd1-4dbb-91cf-e472d0a2ab14 36 fields · synced Jul 18, 2026