Sanhe Meditech Co., Ltd.
ChinaFDA 510(k) applicant, unverified FDA
- Devices
- 6
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What Sanhe Meditech Co., Ltd. makes
Sanhe Meditech Co., Ltd. manufactures laser-based medical devices, including diode laser systems for hair removal, Nd:YAG laser therapy units, and CO₂ laser systems for dermatological procedures.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
- GUDID
- GUDID
- GUDID
Diode Laser Hair Removal Machine (GLD01) Ref K252427
510(k) 510(k)Nd: YAG Laser Therapy Systems Ref K260375
510(k) 510(k)CO2 Laser System Ref K260257
510(k) 510(k)
Company details
- DUNS number
- 443657496
FDA establishments
- Sanhe Meditech Co., Ltd Sanhe Hebei · CN FEI 3027851853
Frequently asked questions
How many devices does Sanhe Meditech Co., Ltd. have in the registry?
The registry currently lists 6 devices for Sanhe Meditech Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sanhe Meditech Co., Ltd.'s devices?
Among its 6 most recently registered devices, Sanhe Meditech Co., Ltd. has devices listed in FDA 510(k) (3 devices) and FDA GUDID (3 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Sanhe Meditech Co., Ltd.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for Sanhe Meditech Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Sanhe Meditech Co., Ltd. in the registry?
The most recently registered devices listed for Sanhe Meditech Co., Ltd. include Diode Laser Hair Removal Machine GLD01, Nd: YAG Laser Therapy Systems GL022, CO2 Laser System GL066 and Diode Laser Hair Removal Machine (GLD01).
Which FDA establishments are linked to Sanhe Meditech Co., Ltd.?
1 FDA establishment is linked to Sanhe Meditech Co., Ltd. in the registry; they are listed on the company page.