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Disposable Subdermal Needle Electrode, twisted
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref S55-638
Identity
- Trade Name
- Disposable Subdermal Needle Electrode, twisted EUDAMEDCNS - Premier Vision FDA UDI
- Generic Name
- Subdermal needle electrode FDA UDI
- Device Name
- Disposable Subdermal Needle Electrode, twisted EUDAMEDDisposable Subdermal Needle Electrode twisted, 13x0.38mm 1.5m 5 lead twisted wire 10sets FDA UDI
- Model / Reference
- S55-638 EUDAMEDFDA UDI
- Description
- Disposable Subdermal Needle Electrode twisted, 13x0.38mm 1.5m 5 lead twisted wire 10sets FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08720791371371 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08720791371371 EUDAMED
- FDA Product Code
- IKT FDA UDIGXZ 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
- 890.1385 FDA UDI882.1350 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
MR Unsafe FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 0.38 Millimeter FDA UDILength — 13 Millimeter FDA UDI
Disposable Subdermal Needle Electrode, twisted 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-08720791371371 | 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 6ac6a37d-5f22-4a99-bcbd-d7d7de7c2763 61 fields · synced Jun 8, 2026
- FDA UDI 640425a6-ef1d-46a1-841a-23e39fea95b5 35 fields · synced May 30, 2026