Shenzhen Goldcare Meditech Co., Ltd.
Country not established FDA
- Devices
- 1
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What Shenzhen Goldcare Meditech Co., Ltd. makes
Shenzhen Goldcare Meditech Co., Ltd. manufactures the GC-3000E, a digital colposcope designed for cervical and vaginal examination in clinical settings. This device integrates digital imaging to assist in the visualization and documentation of tissue abnormalities during gynecological assessments.
The GC-3000E is classified as a Class II medical device and has been submitted for 510(k) clearance through the FDA regulatory pathway. The company is based in the United States.
Catalogue
Gc-3000E Digital Colposcope Ref K122311
Regimes: 510(k) Registry: 510(k)
FDA establishments
- Shenzhen Goldcare Meditech Co., Ltd. Shenzhen Guangdong · CN FEI 3009201600
Frequently asked questions
How many devices does Shenzhen Goldcare Meditech Co., Ltd. have in the registry?
The registry currently lists 1 device for Shenzhen Goldcare Meditech Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Shenzhen Goldcare Meditech Co., Ltd.'s devices?
Among its 1 most recently registered device, Shenzhen Goldcare Meditech Co., Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Shenzhen Goldcare Meditech Co., Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Shenzhen Goldcare Meditech Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Shenzhen Goldcare Meditech Co., Ltd. in the registry?
The most recently registered devices listed for Shenzhen Goldcare Meditech Co., Ltd. include GC-3000E DIGITAL COLPOSCOPE.
Which FDA establishments are linked to Shenzhen Goldcare Meditech Co., Ltd.?
1 FDA establishment is linked to Shenzhen Goldcare Meditech Co., Ltd. in the registry; they are listed on the company page.