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Disposable Hypodermic Needle Electrode
EUDAMEDFDA 510(k)FDA UDIClass IIa (EU MDR)
Ref 202455-000Ref TE/L5050-335Ref 202454-000Ref 202450-000Ref TE/L2530-335510(k) K062437Ref TE/L7570-335Ref 202453-000Ref TE/L3740-335
Identity
- Trade Name
- Disposable Hypodermic Needle Electrode EUDAMEDTechnomed Europe FDA UDI
- Generic Name
- Electromyographic needle electrode, single-use FDA UDI
- Device Name
- Disposable Hypodermic Needle Electrodes EUDAMEDDisposable Hypodermic Needle Electrode, violet hub FDA UDIDisposable Hypodermic Needle Electrode, 0.75m leadwire, red FDA UDI
- Model / Reference
- 202455-000 EUDAMEDFDA UDITE/L5050-335 EUDAMED202454-000 EUDAMED202450-000 EUDAMEDTE/L2530-335 EUDAMEDFDA UDITE/L7570-335 EUDAMED202453-000 EUDAMEDTE/L3740-335 EUDAMED
- Description
- Disposable Hypodermic Needle Electrode, violet hub FDA UDIDisposable Hypodermic Needle Electrode, 0.75m leadwire, red FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08720791377380 EUDAMED08720791377304 EUDAMED08720791377373 EUDAMED08720791377335 EUDAMED08720791377229 EUDAMED08718375865552 EUDAMEDFDA UDI08718375861714 EUDAMEDFDA UDI08720791377328 EUDAMED08720791377366 EUDAMED08720791377267 EUDAMED
- Basic UDI-DI
- B-08720791377380 EUDAMEDB-08720791377304 EUDAMEDB-08720791377373 EUDAMEDB-08720791377335 EUDAMEDB-08720791377229 EUDAMEDB-08720791377328 EUDAMEDB-08718375861714 EUDAMEDB-08720791377366 EUDAMEDB-08718375865552 EUDAMEDB-08720791377267 EUDAMED
- 510(k) Number
- K062437 FDA 510(k)
- FDA Product Code
- IKT FDA 510(k)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 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 890.1385 FDA 510(k)
- Regulation Number
- 890.1385 FDA 510(k)FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Advisory Committee
- Physical Medicine FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- 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
Yes
FDA UDIFDA UDI
MR Unsafe FDA UDI
Dimensions & Sizes
- Size
- Length — 75 Millimeter FDA UDIOuter Diameter — 0.70 Millimeter FDA UDINeedle Gauge — 22 Gauge FDA UDINeedle Gauge — 30 Gauge FDA UDIOuter Diameter — 0.3 Millimeter FDA UDILength — 25 Millimeter FDA UDI
Disposable Hypodermic Needle Electrode by Technomed Europe — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA 510(k), FDA GUDID — regulatory data on deviCERTS
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 | K062437 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-08720791377380 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Technomed Europe
- EUDAMED SRN
- NL-MF-000000064
Sources (13)
- EUDAMED abfa8bb1-5ce5-4639-94d8-25b340ec794e 61 fields · synced Sep 18, 2026
- EUDAMED 7f19731c-35a1-442f-af05-2ce69cb5630d 61 fields · synced May 17, 2026
- EUDAMED 95ebc48e-5824-49e4-9c38-30cbd9e63bee 61 fields · synced May 17, 2026
- EUDAMED e52bb3ac-7f90-48f8-ab07-e79b17cea240 61 fields · synced May 17, 2026
- EUDAMED ed9706a9-bd94-4394-b8ff-79d2d5ec3bff 61 fields · synced May 17, 2026
- FDA 510(k) K062437 24 fields · synced May 18, 2026
- FDA UDI 7bb94928-b194-4c25-96e3-d21c68c435e2 35 fields · synced May 27, 2026
- FDA UDI 0fa89f89-af88-4214-95a9-35398b7b389c 35 fields · synced May 29, 2026
- EUDAMED 1520f0db-85d4-439e-8032-962f3cdab78e 61 fields · synced Jul 9, 2026
- EUDAMED 3ed03560-bc88-4c42-9c2b-5f74154ceca0 61 fields · synced Jul 13, 2026
- EUDAMED 1dc27091-ee28-4f4a-8c0b-14af59ba8876 61 fields · synced Jul 18, 2026
- EUDAMED 6c49d870-0b57-461a-9c02-e8514064b6c7 61 fields · synced Sep 18, 2026
- EUDAMED e2f8c64e-42a4-48f4-8281-4824fd9fa1c3 61 fields · synced Sep 18, 2026