Beijing OrionStar Technology Co., Ltd.
Active in EUDAMEDChinafrom SRN EUDAMED FDA SRN CN-MF-000048929 FEI 3045076265
- Devices
- 6
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA FEI
- Authorised rep.
- SUNGO Europe B.V.NL
Catalogue
- Registry: GUDID
Power Wheelchair (OS-R-M01I) Ref K260053
Regimes: 510(k) Registry: 510(k)Power Wheelchair Ref OS-R-M01I
Regimes: CE MDR Registry: EUDAMEDJazzy Assist Ref OS-R-M01I
Regimes: CE MDR Registry: EUDAMEDPower Wheelchair Ref OS-R-M01A
Regimes: CE MDR Registry: EUDAMEDPower Wheelchair Ref OS-R-M01S
Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID
Company details
- EUDAMED SRN
- CN-MF-000048929
- FDA FEI number
- 3045076265
- DUNS number
- 554413001
- EUDAMED status
- Active
- EUDAMED registered name
- Beijing OrionStar Technology Co., Ltd
- Registered address
- Room 1201-7, 12th Floor, Building 1, Yard 60, Heping West Road, Shijingshan District, 100041, Beijing, China
- [email protected]
- PRRC contact
- Ivy Fang
Frequently asked questions
How many devices does Beijing OrionStar Technology Co., Ltd. have in the registry?
The registry currently lists 6 devices for Beijing OrionStar Technology Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Beijing OrionStar Technology Co., Ltd.'s devices?
Among its 6 most recently registered devices, Beijing OrionStar Technology Co., Ltd. has devices listed in EUDAMED (4 devices), FDA 510(k) (1 device) and FDA GUDID (2 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Beijing OrionStar Technology Co., Ltd.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for Beijing OrionStar Technology Co., Ltd.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Beijing OrionStar Technology Co., Ltd. in the registry?
The most recently registered devices listed for Beijing OrionStar Technology Co., Ltd. include Power wheelchair OS-R-M01I, Power Wheelchair (OS-R-M01I), Power Wheelchair and Jazzy Assist.