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Disposable Concentric Needle Electrode
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref TE/B50600-003
Identity
- Trade Name
- Disposable Concentric Needle Electrode EUDAMEDTechnomed Europe FDA UDI
- Generic Name
- Electromyographic needle electrode, single-use FDA UDI
- Device Name
- Disposable Concentric Needle Electrode EUDAMEDDisposable Concentric Needle Electrode, 37x0.45mm Green 25 pcs FDA UDI
- Model / Reference
- TE/B50600-003 EUDAMEDFDA UDI
- Description
- Disposable Concentric Needle Electrode, 37x0.45mm Green 25 pcs FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08720791376086 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08720791376086 EUDAMED
- FDA Product Code
- GXZ FDA UDIIKT FDA UDI
- EMDN Code
- N010101 ELECTROMYOGRAPHIC ELECTRODES EUDAMED
- GMDN Term
- Electromyographic needle electrode, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 882.1350 FDA UDI890.1385 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 37 Millimeter FDA UDIOuter Diameter — 0.45 Millimeter FDA UDINeedle Gauge — 26 Gauge FDA UDI
Disposable Concentric Needle Electrode by Technomed Europe — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08720791376086 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Technomed Europe
- EUDAMED SRN
- NL-MF-000000064
Sources (2)
- EUDAMED 313a8653-7406-46e4-a5f5-03fe4c469fa6 61 fields · synced Jul 25, 2026
- FDA UDI 6e1b6692-7732-44a0-968d-b4cb1bdc81cc 35 fields · synced May 30, 2026