Technomed Europe
Disposable Subdermal Needle Electrode corkscrew, 1.5m wire, 4x6 colors, 24pcs with Protection Cap
2manufacturers in China registered for this device type
92catalogue numbers in this listing
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 | Technomed Engineering B.V. |
|---|---|
| FDA product code | IKT |
| Device type | Electrode, Needle, Diagnostic Electromyograph |
| Device class | Class 2 |
| Regulation | 21 CFR 890.1385 |
| 510(k) | K241045 |
| Record published | 2017-10-02 |
| Record revised | 2025-02-17 (version 6) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization, Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Shelfbox of 25, shelfbox of 10, shelfbox of 24, shelfbox of 12, pack of 10, shelf box of 10 |
| Sizes | Outer diameter 0.3 to 0.7 mm; needle gauge 22 to 30 G; length 6 to 75 mm; length 1.2 to 2.5 m |
| Distribution end date | 2023-07-13 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 202450-000 | Needle Gauge 30 G | In distribution |
| 202466-000 | Needle Gauge 28 G | In distribution |
| TE/L2530-335 | Needle Gauge 30 G | In distribution |
| 202464-000 | Needle Gauge 28 G | In distribution |
| TE/S50716-002 | Needle Gauge 27 G | In distribution |
| TE/S50723-001 | Length 6 mm | In distribution |
| TE/S50715-004-C | Length 1.5 m | In distribution |
| TE/L3740-335 | Length 37 mm | In distribution |
| TE/AP3735-335/01 | Needle Gauge 28 G | In distribution |
| TE/S50715-001-C | Needle Gauge 23 G | In distribution |
| TE/S50715-001-C | Needle Gauge 23 G | In distribution |
| TE/S50718-001 | Needle Gauge 30 G | In distribution |
| TE/S50715-004-C | Length 1.5 m | In distribution |
| 202453-000 | Length 37 mm | In distribution |
| TE/AD2545-008 | Needle Gauge 26 G | In distribution |
| TE/AD7545-008 | Needle Gauge 26 G | In distribution |
| 202459-000 | Length 37 mm | In distribution |
| TE/S45-838 | Needle Gauge 26 G | In distribution |
| 202451-000 | Length 25 mm | In distribution |
| TE/S50725-004 | Needle Gauge 23 G | In distribution |
| TE/AD2545-008/01 | Needle Gauge 26 G | In distribution |
| TE/L5050-335 | Length 50 mm | In distribution |
| TE/L3745-335 | Length 37 mm | In distribution |
| TE/S45-638 | Needle Gauge 26 G | In distribution |
| TE/S50725-001 | Needle Gauge 23 G | In distribution |
| 202452-000 | Needle Gauge 27 G | In distribution |
| TE/AD3735-008/01 | Needle Gauge 28 G | In distribution |
| TE/S50715-004 | Length 1.5 m | In distribution |
| 202455-000 | Length 75 mm | In distribution |
| TE/AD5045-008/01 | Needle Gauge 26 G | In distribution |
| TE/B50700-005 | In distribution | |
| TE/AP7545-335/01 | Needle Gauge 26 G | In distribution |
| TE/S55-938 | Outer Diameter 0.38 mm | In distribution |
| TE/S50725-001-C | Needle Gauge 23 G | In distribution |
| TE/L7570-335 | Length 75 mm | In distribution |
| TE/B50700-003 | In distribution | |
| TE/S22-837 | Needle Gauge 30 G | In distribution |
| TE/S50725-001-C | Needle Gauge 23 G | In distribution |
| TE/L2540-335 | Length 25 mm | In distribution |
| TE/AP2545-335/01 | Needle Gauge 26 G | In distribution |
| TE/S50725-003 | Needle Gauge 23 G | In distribution |
| TE/S50716-004 | Needle Gauge 27 G | In distribution |
| TE/S49-438 | Needle Gauge 26 G | In distribution |
| TE/S50725-001 | Needle Gauge 23 G | In distribution |
| TE/L3745-335 | Length 37 mm | In distribution |
| TE/S50725-003 | Needle Gauge 23 G | In distribution |
| 202457-000 | Length 25 mm | In distribution |
| TE/L5050-335 | Length 50 mm | In distribution |
| TE/S56-638 | Outer Diameter 0.38 mm | In distribution |
| TE/B50600-004 | Needle Gauge 26 G | In distribution |
| TE/AD3735-008 | Needle Gauge 28 G | In distribution |
| TE/L7570-335 | Length 75 mm | In distribution |
| TE/S50725-004 | Needle Gauge 23 G | In distribution |
| TE/AD3745-008/01 | Needle Gauge 26 G | In distribution |
| TE/S50725-001-C | Needle Gauge 23 G | In distribution |
| TE/AD3745-008 | Needle Gauge 26 G | In distribution |
| TE/B50700-006 | In distribution | |
| TE/S50725-004 | Needle Gauge 23 G | In distribution |
| TE/L3740-335 | Length 37 mm | In distribution |
| TE/S50722-004 | Length 19 mm | In distribution |
| TE/S46-638 | Needle Gauge 27 G | In distribution |
| TE/S56-938 | Outer Diameter 0.38 mm | In distribution |
| 202454-000 | Needle Gauge 25 G | In distribution |
| TE/AP2535-335 | Needle Gauge 28 G | In distribution |
| TE/S50716-003 | Needle Gauge 27 G | In distribution |
| ML-0471S | Needle Gauge 27 G | In distribution |
| TE/S50715-004 | Length 1.5 m | In distribution |
| TE/AD2535-008/01 | Needle Gauge 28 G | In distribution |
| TE/S50715-001 | Needle Gauge 23 G | In distribution |
| TE/S50722-001 | Length 13 mm | In distribution |
| TE/B50600-004 | Needle Gauge 26 G | In distribution |
| TE/AP3745-335 | Needle Gauge 26 G | In distribution |
| TE/S49-938 | Needle Gauge 26 G | In distribution |
| 202468-000 | Needle Gauge 26 G | In distribution |
| 202461-000 | Length 75 mm | In distribution |
| TE/AD5045-008 | Needle Gauge 26 G | In distribution |
| TE/S55-638 | Outer Diameter 0.38 mm | In distribution |
| TE/L2540-335 | Length 25 mm | In distribution |
| TE/AD7545-008/01 | Needle Gauge 26 G | In distribution |
| TE/S50715-001-C | Needle Gauge 23 G | In distribution |
| TE/S50715-001 | Needle Gauge 23 G | In distribution |
| TE/S42-937 | Length 14 mm | In distribution |
| TE/L2530-335 | Needle Gauge 30 G | In distribution |
| TE/AP5045-335 | Needle Gauge 26 G | In distribution |
| TE/S51-634 | Needle Gauge 27 G | Withdrawn |
| TE/B50600-003 | Needle Gauge 26 G | Withdrawn |
| TE/B50600-004 | Needle Gauge 30 G | Withdrawn |
| TE/S61-634 | Needle Gauge 27 G | Withdrawn |
| TE/S57-014 | Needle Gauge 27 G | Withdrawn |
| TE/S68-012 | Needle Gauge 27 G | Withdrawn |
| TE/S61-434 | Needle Gauge 27 G | Withdrawn |
| TE/B50600-005 | Needle Gauge 30 G | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Disposable EMG needle electrodes | Spes Medica Srl | 122 |
| 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 |
| Teca Elite | Natus Manufacturing Limited | 11 |
Showing 12 of 39. All products under Electrode, Needle, Diagnostic Electromyograph
Recalls Naming This Product
2 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Technomed Europe | UDI-DI | 2022-08-09 | Class II | Labeling Change Control | Burns of varying degrees can occur to patients with electrodes left in while in the MRI scanner as a result of inadequate safety information in the IFU. | 37/25-electrode boxes | 2024-04-11 |
| Technomed Europe | UDI-DI | 2021-12-08 | Class II | Device Design | There is a high risk of the blue hub detaching from the corkscrew needle, resulting the the needle remaining in the patient’s scalp. | 117,672 devices | 2024-05-31 |
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.