Neuroline ConcentricNeurology Needle Electrodes
6 catalogue numbers from 74030-35/25, listed by Ambu A/S, Denmark, under Electrode, Needle, Diagnostic Electromyograph. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
6catalogue numbers in this listing
2510(k) clearances naming this product code
Who Else Makes It
Concentrated in Shandong (1), Guangdong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Pine Moon Electronics Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
| BIO Protech Yantai Inc | Yantai | Shandong | Manufacturer | 12 |
Record
| Listed by | Ambu A/S, Denmark |
|---|---|
| FDA product code | IKT |
| Device type | Electrode, Needle, Diagnostic Electromyograph |
| Device class | Class 2 |
| Regulation | 21 CFR 890.1385 |
| Establishment | Specification developer, Private-label distributor, Manufacturer, Exporter |
| Record published | 2016-09-22 |
| Record revised | 2026-01-30 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 10 to 25 °C; Handling environment temperature 10 to 25 °C |
| Packaging | Pack of 16, pack of 25 |
| Sizes | Length 25 to 75 mm; lumen/inner diameter 0.3 to 0.65 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 74030-35/25 | Length 30 mm | In distribution |
| 74075-65/25 | Length 75 mm | In distribution |
| 74025-45/25 | Lumen/Inner Diameter 0.45 mm | In distribution |
| 74050-45/25 | Lumen/Inner Diameter 0.45 mm | In distribution |
| 74025-30/25 | Length 25 mm | In distribution |
| 74038-45/25 | Lumen/Inner Diameter 0.45 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Disposable EMG needle electrodes | Spes Medica Srl | 122 |
| Technomed Europe | Technomed Engineering B.V. | 92 |
| Cadwell | Technomed Engineering B.V. | 42 |
| Chalgren | Chalgren Enterprises, Inc. | 42 |
| Rhythmlink® | Rhythmlink International, LLC | 39 |
| Electrode, Needle, Diagnostic Electromyograph | Neurovision Medical Products, Inc. | 38 |
| MediMax Tech | Medimax Tech Inc. | 19 |
| Bio Protech | BIO Protech USA, Inc. | 19 |
| UltraPoint™ | Rochester Electro Medical, Inc. | 18 |
| Bionen | Bionen SAS DI Barbara Nencioni & C. | 17 |
| Natus Neurology | Natus Neurology Incorporated | 13 |
| Neuroguard | Technomed Engineering B.V. | 11 |
Showing 12 of 39. All products under Electrode, Needle, Diagnostic Electromyograph
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K093825 | 2010-01-13 |
| K071186 | 2007-07-30 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.