Cathay Manufacturing Corp.
Manufacturer and brand owner in Shanghai, China. 5 device types, 4 products catalogued, 2 clearances.
Cathay Manufacturing Corp. is a contract manufacturer holding a current FDA establishment registration. The registration covers Cable, Electrode, Electrode, Cutaneous and 3 other device types. 4 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2008.
Registration
| Status | Registered |
|---|---|
| Registration expires | 2026 |
| Registration number | 3009555600 |
| FEI number | 3009555600 |
| DUNS | 421287342 |
| Establishment type | Contract manufacturer, Specification developer, Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 上海韩洁电子科技有限公司 |
|---|---|
| Source | Baidu Baike |
Location
| City | Shanghai |
|---|---|
| Province | Shanghai |
| Address | No. 328, Xishe Road, Maogang Town |
| Postal code | 201607 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Cable, Electrode | Class 2 | Electrode Cable, TENS Cable, Cathay | 2013 | 47 |
| Electrode, Cutaneous | Class 2 | Cathay, FlexTone replacement electrodes | 2008 | 47 |
| Electrode, Electrocardiograph | Class 2 | Cathay | 2018 | 33 |
| Electrosurgical, Cutting & Coagulation & Accessories | Class 2 | Cathay, Disposable Neutral Electrode | 2013 | 65 |
| Generator, Lesion, Radiofrequency | Class 2 | 2026 | 2 |
Own-Brand Listings
Clearances
2 clearances name Cathay Manufacturing Corp. as applicant. 3 are held by other companies and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K160081 | 2016-10-19 | GXY | Traditional | This company |
| K130027 | 2013-08-22 | GEI | Traditional | This company |
| K203293 | 2022-01-21 | GXD | Traditional | Abbott Medical |
| K170369 | 2018-07-19 | GEI | Traditional | Cathay Manfacturing Corp. |
| K020735 | 2002-07-12 | GXY | Traditional | Cathay International, Ltd. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2011 |
|---|---|
| Main products | Electrosurgical pencils, Electrosurgical grounding pads, TENS electrodes, ECG electrodes, Electrode tips |
| Certifications | ISO13485, CE, FDA 510(k), SFDA, Free Sales |
Nearby Manufacturers
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.
The manufacturer named here can complete this record.