Zhuzhou Goldenhot Medical Technology Co., Ltd.
ChinaFDA applicant, unverified FDA
- Devices
- 3
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What Zhuzhou Goldenhot Medical Technology Co., Ltd. makes
The company manufactures intense pulsed light (IPL) devices for skin treatments and hair removal, including models with varying wavelength and power settings. It also produces medical electronic thermometers for clinical temperature measurement.
These devices are classified as Class II under FDA regulations and are listed via 510(k) premarket notifications. The company operates in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
IPL Hair Removal Device (DE03A-W, DE03A-P, DE03A-V, DE03A-G, DE03B-W, DE03B-P, DE03B-V, DE03B-G) Ref K243085
Regimes: 510(k) Registry: 510(k)Medical electronic thermometer (FC01, FC02) Ref K240109
Regimes: 510(k) Registry: 510(k)
FDA establishments
- Zhuzhou Goldenhot Medical Technology Co., Ltd Zhuzhou Hunan · CN FEI 3027847716
Frequently asked questions
How many devices does Zhuzhou Goldenhot Medical Technology Co., Ltd. have in the registry?
The registry currently lists 3 devices for Zhuzhou Goldenhot Medical Technology Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Zhuzhou Goldenhot Medical Technology Co., Ltd.'s devices?
Among its 3 most recently registered devices, Zhuzhou Goldenhot Medical Technology Co., Ltd. has devices listed in FDA 510(k) (3 devices).
What risk classes do Zhuzhou Goldenhot Medical Technology Co., Ltd.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Zhuzhou Goldenhot Medical Technology Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Zhuzhou Goldenhot Medical Technology Co., Ltd. in the registry?
The most recently registered devices listed for Zhuzhou Goldenhot Medical Technology Co., Ltd. include Intense pulsed light device, Model(s): DE01A-B, DE01A-G, DE01B-B, DE01B-G, DE01C-B, DE01C-G, DE02A-B, DE02A-G, DE02B-B, DE02B-G, DE02C-B, DE02C-G., IPL Hair Removal Device (DE03A-W, DE03A-P, DE03A-V, DE03A-G, DE03B-W, DE03B-P, DE03B-V, DE03B-G) and Medical electronic thermometer (FC01, FC02).
Which FDA establishments are linked to Zhuzhou Goldenhot Medical Technology Co., Ltd.?
1 FDA establishment is linked to Zhuzhou Goldenhot Medical Technology Co., Ltd. in the registry; they are listed on the company page.