Natus
NCS 30-Patient Kit, Tab Electrodes, 60 each Bar, Ring, and Ground Electrodes Use with alligator-clip lead wires
47manufacturers in China registered for this device type
66catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (29), Jiangsu (4), Zhejiang (4). 7 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Shenzhen Konmed Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
| China Qingdao Bright Medical Manufacturing Co., Ltd. | Qingdao | Shandong | Contract manufacturer | 8 |
| Pine Moon Electronics Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
| Top-rank Health Care Co., Ltd. | Shaoxing | Zhejiang | Contract manufacturer | 7 |
| Omron (Dalian) Co., Ltd. (Plant 1) | Dalian | Liaoning | Contract manufacturer | 7 |
| Shenzhen Zifound Infonet Technology Co., Ltd. | Shenzhen, Guandong | Guangdong | Contract manufacturer | 2 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
| Beijing Choice Electronic Technololgy Co., Ltd. | Beijing | Beijing | Repacker / relabeller | 30 |
| Taizhou Chenguang Import AND Export Trading Co., Ltd. | Taizhou | Jiangsu | Exporter | 25 |
Showing 12 of 47. All 47 manufacturers in China registered for Electrode, Cutaneous
Record
| Listed by | Natus Neurology Incorporated, United States |
|---|---|
| FDA product code | GXY |
| Device type | Electrode, Cutaneous |
| Device class | Class 2 |
| Regulation | 21 CFR 882.1320 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K850108 |
| Record published | 2016-09-22 |
| Record revised | 2022-11-28 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Distribution end date | 2023-10-25 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 019-433800 | In distribution | |
| 019-420100 | In distribution | |
| 019-414100 | In distribution | |
| 019-446700 | In distribution | |
| 019-431400 | In distribution | |
| 019-417700 | In distribution | |
| 019-767700 | In distribution | |
| 019-421500 | In distribution | |
| 019-414600 | In distribution | |
| 454040 | In distribution | |
| 019-435500 | In distribution | |
| 019-405500 | In distribution | |
| N6003 | In distribution | |
| 019-414400 | In distribution | |
| 019-427000 | In distribution | |
| 019-422200 | In distribution | |
| 019-409000 | In distribution | |
| 019-401400 | In distribution | |
| 019-439400 | In distribution | |
| 454010 | In distribution | |
| 019-413900 | In distribution | |
| 443020 | In distribution | |
| 019-415200 | In distribution | |
| N2025 | In distribution | |
| 019-435300 | In distribution | |
| 019-746802 | In distribution | |
| 454030 | In distribution | |
| 019-414200 | In distribution | |
| 019-421000 | In distribution | |
| 019-400400 | In distribution | |
| 019-428400 | In distribution | |
| 019-741901 | In distribution | |
| 019-405900 | In distribution | |
| 443010 | In distribution | |
| 019-429400 | In distribution | |
| 019-415000 | In distribution | |
| 019-434700 | In distribution | |
| 019-406600 | In distribution | |
| 019-409100 | In distribution | |
| 454020 | In distribution | |
| 019-420800 | In distribution | |
| 019-768500 | In distribution | |
| 019-415900 | In distribution | |
| 019-401500 | In distribution | |
| 019-439300 | In distribution | |
| 019-429300 | In distribution | |
| 019-417600 | In distribution | |
| 019-400500 | In distribution | |
| 019-401200 | In distribution | |
| 019-477500 | Withdrawn | |
| 019-477700 | Withdrawn | |
| 019-478700 | Withdrawn | |
| 019-479100 | Withdrawn | |
| 019-477200 | Withdrawn | |
| 019-477600 | Withdrawn | |
| 019-478800 | Withdrawn | |
| 019-478900 | Withdrawn | |
| 019-477300 | Withdrawn | |
| 019-479200 | Withdrawn | |
| 019-478400 | Withdrawn | |
| 019-477400 | Withdrawn | |
| 019-478600 | Withdrawn | |
| 019-478500 | Withdrawn | |
| 019-479000 | Withdrawn | |
| 019-477800 | Withdrawn | |
| 019-477900 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Rhythmlink® | Rhythmlink International, LLC | 455 |
| waveguard | Eemagine Medical Imaging Solutions Gmbh | 166 |
| Espire Elbow Hybrid | College Park Industries | 138 |
| Technomed Europe | Technomed Engineering B.V. | 126 |
| Cadwell | Technomed Engineering B.V. | 111 |
| The Electrode Store | Impulse Technology LLC | 109 |
| Electrode, Cutaneous | Gmdasz Manufacturing Co., Ltd. | 99 |
| Auvon | Shenzhen Yuwen E-Commerce Co., Ltd. | 93 |
| AdvanTrode | Pepin Manufacturing, Inc. | 78 |
| Uni-Patch | Cardinal Health | 77 |
| Alpha | WillowWood Global LLC | 68 |
| Espire Elbow Pro | College Park Industries | 67 |
Showing 12 of 1,006. All products under Electrode, Cutaneous
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.