Shenzhen Soga Technology Co., Ltd.
Active in EUDAMEDChinafrom SRN EUDAMED FDA SRN CN-MF-000023134 FEI 3018318562
- Devices
- 4
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA FEI
What Shenzhen Soga Technology Co., Ltd. makes
Shenzhen Soga Technology Co., Ltd. manufactures dental diode lasers, including the SOGA Laser and ILaser II, designed for precision dental procedures.
Their products are classified as Class II devices and are listed under the FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
Soga Ref Aurora-S
Regimes: CE MDR Registry: EUDAMED- Regimes: 510(k) Registry: 510(k)
Dental diode laser, SOGA Laser, ILaser II Ref K211150
Regimes: 510(k) Registry: 510(k)Dental diode laser Ref K214008
Regimes: 510(k) Registry: 510(k)
Company details
- EUDAMED SRN
- CN-MF-000023134
- FDA FEI number
- 3018318562
- EUDAMED status
- Active
- EUDAMED registered name
- Shenzhen Soga Technology Co., Ltd.
- EUDAMED abbreviated name
- Shenzhen SOGA
- Registered address
- Room102, 1st Floor;2nd Floor Room 302, 3rd Floor, Workshop Building 1 Second Industrial Zone No. 16, Guanghui Road, Changpai Community Shiyan Street, Bao 'an District Shenzhen Guangdong 518108, China, 518108, Shenzhen, China
- Website
- dentalsoga.com/
- [email protected]
- PRRC contact
- Dongbin Cai
Frequently asked questions
How many devices does Shenzhen Soga Technology Co., Ltd. have in the registry?
The registry currently lists 4 devices for Shenzhen Soga Technology Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Shenzhen Soga Technology Co., Ltd.'s devices?
Among its 4 most recently registered devices, Shenzhen Soga Technology Co., Ltd. has devices listed in EUDAMED (1 device) and FDA 510(k) (3 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Shenzhen Soga Technology Co., Ltd.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Shenzhen Soga Technology Co., Ltd.'s devices are Class IIb and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Shenzhen Soga Technology Co., Ltd. in the registry?
The most recently registered devices listed for Shenzhen Soga Technology Co., Ltd. include SOGA, SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy system family of the Dental diode laser ( ILaser III Pro), Dental diode laser, SOGA Laser, ILaser II and Dental diode laser.