Shenzhen Goldcare Meditech Co., Ltd.
Registered establishment in Shenzhen, Guangdong, China. 2 device types, 1 clearance.
Shenzhen Goldcare Meditech Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Colposcope (And Colpomicroscope), Colposcope (And Colpomicroscope), Exempt. Its earliest product listing with the FDA dates from 2016.
2device types registered with the FDA
1510(k) clearance
Registration
| Registered name | SHENZHEN GOLDCARE MEDITECH CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3009201600 |
| FEI number | 3009201600 |
| Establishment type | Contract manufacturer, Manufacturer |
Chinese Registration
| Chinese legal name | 深圳市金舜康医疗科技有限公司 |
|---|---|
| Source | export sales certificate, Guangdong medical products administration |
Location
| City | Shenzhen |
|---|---|
| Province | Guangdong |
| Address | 902, Building C, Jinweiyuan Industrial Park, 41 Qingsong Road, Zhukeng Community, Longtian Street |
| Postal code | 518118 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Colposcope (And Colpomicroscope) | Class 2 | AL-106, AL-106SA AND AL-106B Medgyn Digital Video Colposcope | 2016 | 4 |
| Colposcope (And Colpomicroscope), Exempt | Class 2 | GC-8000E Digital Video Colposcope, GC-5000E Digital Video Colposcope, G9 Digital Video Colposcope, GC-3000E Digital Video Colposcope | 2025 | 4 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K122311 | 2013-09-18 | HEX | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2007 |
|---|---|
| Main products | Digital video colposcope, Video colposcope (GC-3000E), Video colposcope (G9), Colposcope accessories |
| Certifications | FDA, CE, ISO |
| Export markets | Global distributors and healthcare practitioners |
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.