Cadwell 202459-000
Ref 202459-000
Active
CE MDD
Valid until
Not listed
FDA recalls
Not checked
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD EUDAMED | NumberB-08720791376673 08720791376673 | Date12 Feb 2025 | StatusActive |
| United States | GUDID listing GUDID | Number08720791376673 | Date12 Feb 2025 | StatusListed |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- Disposable Concentric Needle Electrode EUDAMEDCadwell GUDID
- Generic Name
- Electromyographic needle electrode, single-use
- Device Name
- Disposable Concentric Needle Electrodes
- Model / Reference
- 202459-000
- Primary DI / UDI-DI
- 08720791376673
- Basic UDI-DI
- B-08720791376673
- FDA Product Code
- IKT, GXZ
- EMDN Code
- N010101 Electromyographic electrodes
- GMDN Term
- Electromyographic needle electrode, single-use
- Device Class
- Class IIa EUDAMEDClass II GUDID
- Regulation Number
- 890.1385, 882.1350
- EU market of registration
- Netherlands
- GUDID distribution status
- In Commercial Distribution
- MRI Safety
- MR Unsafe
- Size
- Length — 37 MillimeterOuter Diameter — 0.45 MillimeterNeedle Gauge — 26 Gauge
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class IIa | Class II |
Other devices from Technomed Engineering B.V.
Properties
Other properties (18)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No