Identity
- Trade Name
- Technomed Europe FDA UDI
- Generic Name
- Electromyographic needle electrode, single-use FDA UDI
- Device Name
- Disposable Concentric Needle Electrode, Blue FDA UDI
- Model / Reference
- TE/B50600-004 FDA UDI
- Description
- Disposable Concentric Needle Electrode, Blue FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08718375865941 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
- Not 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
- Needle Gauge — 30 Gauge FDA UDIOuter Diameter — 0.3 Millimeter FDA UDILength — 30 Millimeter FDA UDI
Technomed Europe by Technomed Engineering B.V. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 a51e841f-dc17-449c-8c62-efc3a3723e30 36 fields · synced May 30, 2026