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Disposable Concentric Needle Electrode
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 202460-000Ref 202456-000Ref 202459-000Ref 202457-000Ref TE/B50600-002Ref TE/B50600-006Ref TE/B50600-005
Identity
- Trade Name
- Disposable Concentric Needle Electrode EUDAMEDCadwell FDA UDITechnomed Europe FDA UDI
- Generic Name
- Electromyographic needle electrode, single-use FDA UDI
- Device Name
- Disposable Concentric Needle Electrodes EUDAMEDDisposable Concentric Needle Electrode EUDAMEDDisposable Concentric Needle Electrode, 37x0.45mm Green 25 pcs FDA UDIDisposable Concentric Needle Electrode, yellow hub FDA UDIDisposable Concentric Needle Electrode, 25x0.4mm Yellow 25 pcs FDA UDIDisposable Concentric Needle Electrode, 30x0.3mm Pink 25 pcs FDA UDIDisposable Concentric Needle Electrode, blue hub FDA UDIDisposable Concentric Needle Electrode, red hub FDA UDIDisposable Concentric Needle Electrode, 75x0.6mm Violet 25 pcs FDA UDI
- Model / Reference
- 202460-000 EUDAMEDFDA UDI202459-000 EUDAMEDFDA UDI202457-000 EUDAMEDFDA UDITE/B50600-002 EUDAMEDFDA UDITE/B50600-006 EUDAMEDFDA UDI202456-000 EUDAMEDFDA UDITE/B50600-005 EUDAMEDFDA UDI
- Description
- Disposable Concentric Needle Electrode, 37x0.45mm Green 25 pcs FDA UDIDisposable Concentric Needle Electrode, yellow hub FDA UDIDisposable Concentric Needle Electrode, 25x0.4mm Yellow 25 pcs FDA UDIDisposable Concentric Needle Electrode, 30x0.3mm Pink 25 pcs FDA UDIDisposable Concentric Needle Electrode, blue hub FDA UDIDisposable Concentric Needle Electrode, red hub FDA UDIDisposable Concentric Needle Electrode, 75x0.6mm Violet 25 pcs FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08718375865606 EUDAMEDFDA UDI08720791376673 EUDAMEDFDA UDI08718375865576 EUDAMEDFDA UDI08720791376062 EUDAMEDFDA UDI08720791376147 EUDAMEDFDA UDI08718375865569 EUDAMEDFDA UDI08720791376123 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08718375865606 EUDAMEDB-08718375865569 EUDAMEDB-08720791376673 EUDAMEDB-08718375865576 EUDAMEDB-08720791376062 EUDAMEDB-08720791376147 EUDAMEDB-08720791376123 EUDAMED
- FDA Product Code
- IKT FDA UDIGXZ 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
- 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
Yes
FDA UDIFDA UDI
MR Unsafe FDA UDI
Dimensions & Sizes
- Size
- Length — 37 Millimeter FDA UDIOuter Diameter — 0.45 Millimeter FDA UDINeedle Gauge — 26 Gauge FDA UDILength — 25 Millimeter FDA UDIOuter Diameter — 0.40 Millimeter FDA UDINeedle Gauge — 27 Gauge FDA UDIOuter Diameter — 0.4 Millimeter FDA UDILength — 30 Millimeter FDA UDIOuter Diameter — 0.3 Millimeter FDA UDINeedle Gauge — 30 Gauge FDA UDILength — 50 Millimeter FDA UDIOuter Diameter — 0.30 Millimeter FDA UDILength — 75 Millimeter FDA UDIOuter Diameter — 0.6 Millimeter FDA UDINeedle Gauge — 23 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-08718375865606 | 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 (15)
- EUDAMED 01bb07d3-251f-4c1e-ac73-eaab9cb0c0e5 61 fields · synced Aug 2, 2026
- FDA UDI 7a6188b7-0998-4db7-bd59-5412bf75d53a 35 fields · synced May 24, 2026
- FDA UDI 9f2243d1-61f6-48ef-ad73-869581b30e7e 35 fields · synced May 29, 2026
- FDA UDI 4d5780b7-255e-4ab1-87a2-f8589e68534b 35 fields · synced May 30, 2026
- FDA UDI 9586e8c0-08e5-4486-9a84-2f9afbe25fce 35 fields · synced May 30, 2026
- FDA UDI 6b2cccdd-7707-433f-8492-293d9a0f12d8 35 fields · synced May 30, 2026
- FDA UDI 50bc337a-21b4-4ae3-97c8-7fd302bee810 35 fields · synced May 30, 2026
- FDA UDI 844e0781-1f46-42c1-9323-a0d904689925 35 fields · synced May 30, 2026
- EUDAMED 451e6b7b-74ee-4b7f-bb7f-b275a4f1e956 61 fields · synced Jun 20, 2026
- EUDAMED eda3730b-ddf2-4c16-8b68-65f199c65515 61 fields · synced Jul 9, 2026
- EUDAMED 8a914eed-20e9-4d72-8bbf-1914ff0b6642 61 fields · synced Jul 12, 2026
- EUDAMED fb83502f-6f98-4b45-87ca-bc7601184fea 61 fields · synced Jul 18, 2026
- EUDAMED 8be567d0-1f19-4f3c-8a3a-6bf4d85c30f4 61 fields · synced Jul 24, 2026
- EUDAMED adf663d8-cbd1-4bae-8376-402c663d566e 61 fields · synced Jul 28, 2026
- EUDAMED f74e4265-1bef-473f-8ac1-7a4d55f88d76 61 fields · synced Aug 2, 2026