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Disposable Subdermal Needle Electrode, Pt/Ir
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref TE/S46-638/01
Identity
- Trade Name
- Disposable Subdermal Needle Electrode, Pt/Ir EUDAMEDTechnomed Europe FDA UDI
- Generic Name
- Subdermal needle electrode FDA UDI
- Device Name
- Disposable Subdermal Needle Electrodes EUDAMEDDisposable Subdermal Needle Electrode 12x0.4mm Pt/Ir 1.36m wire 5x5 colors 25pcs FDA UDI
- Model / Reference
- TE/S46-638/01 EUDAMEDFDA UDI
- Description
- Disposable Subdermal Needle Electrode 12x0.4mm Pt/Ir 1.36m wire 5x5 colors 25pcs FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08718375867785 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08718375867785 EUDAMED
- FDA Product Code
- GXZ 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 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
Dimensions & Sizes
- Size
- Needle Gauge — 27 Gauge FDA UDIOuter Diameter — 0.4 Millimeter FDA UDILength — 12 Millimeter FDA UDI
Disposable Subdermal Needle Electrode, Pt/Ir 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-08718375867785 | 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 b260044f-cbe2-4f23-a06c-0f33d73b2495 61 fields · synced Jun 18, 2026
- FDA UDI 4a7922e0-4ba9-4bd6-a728-039ed9cb2981 35 fields · synced May 30, 2026