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Disposable Subdermal Needle Electrode, corkscrew
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref S50715-003-C510(k) K241045Ref TE/S50715-004Ref SO-ELCS20
Identity
- Trade Name
- Disposable Subdermal Needle Electrode, corkscrew EUDAMEDNeuroguard FDA UDI
- Generic Name
- Subdermal needle electrode FDA UDI
- Device Name
- Disposable Subdermal Needle Electrodes EUDAMEDDisposable Subdermal Needle Electrode, corkscrew, 2.5m wire 4x6 colors 24pcs with Protection Cap FDA UDI
- Model / Reference
- S50715-003-C EUDAMEDFDA UDITE/S50715-004 EUDAMEDSO-ELCS20 EUDAMED
- Description
- Disposable Subdermal Needle Electrode, corkscrew, 2.5m wire 4x6 colors 24pcs with Protection Cap FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08720791370671 EUDAMEDFDA UDI08718375863473 EUDAMED08718375865392 EUDAMED
- Basic UDI-DI
- B-08720791370671 EUDAMEDB-08718375863473 EUDAMEDB-08718375865392 EUDAMED
- FDA Product Code
- GXZ FDA UDIIKT FDA UDI
- EMDN Code
- N01010202 EEG EXTRACRANIC ELECTRODES EUDAMED
- GMDN Term
- Subdermal needle electrode 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
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
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
MR Unsafe FDA UDI
Dimensions & Sizes
- Size
- Length — 2.5 Meter FDA UDIOuter Diameter — 0.6 Millimeter FDA UDINeedle Gauge — 23 Gauge FDA UDI
Disposable Subdermal Needle Electrode, corkscrew by Technomed Europe — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA GUDID, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K241045 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-08720791370671 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Technomed Europe
- EUDAMED SRN
- NL-MF-000000064
Sources (5)
- EUDAMED 009dc662-54ce-426d-8ea1-794f10bd60d6 85 fields · synced Aug 3, 2026
- EUDAMED e7be7050-e09d-4356-a403-545c8d387eca 61 fields · synced May 17, 2026
- EUDAMED ad2b9923-0cab-41e0-b8bd-486b7a52437e 61 fields · synced May 18, 2026
- FDA UDI 669d6ec8-45d8-4e7d-bf14-fd04ec554c34 35 fields · synced May 25, 2026
- FDA 510(k) K241045 1 fields · synced May 18, 2026