Xiamen Yizhou Imp. & Exp. Co., Ltd.
Active in EUDAMEDChinafrom SRN EUDAMED FDA SRN CN-MF-000044042 FEI 3008763803
- Devices
- 2
- 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
What Xiamen Yizhou Imp. & Exp. Co., Ltd. makes
Xiamen Yizhou Imp. & Exp. Co., Ltd. makes dental devices such as Anti Grinding Guard and Mouth Guard.
The company's portfolio includes devices classified as Class I and U, and is listed in regulatory registries including eudamed and fda_510k, with the company based in China.
Catalogue
Anti Grinding Guard Ref K240810
Regimes: 510(k) Registry: 510(k)Mouth Guard Ref YZ1507
Regimes: CE MDR Registry: EUDAMED
Company details
- EUDAMED SRN
- CN-MF-000044042
- FDA FEI number
- 3008763803
- EUDAMED status
- Active
- EUDAMED registered name
- Xiamen Yizhou Imp. & Exp. Co., Ltd.
- Registered address
- 2F, 1#, Huli Industrial Park, Meixi Road, Tong An District,, 361001, Xiamen City, Fujian, China
- [email protected]
- PRRC contact
- ENXIA HUANG
Frequently asked questions
How many devices does Xiamen Yizhou Imp. & Exp. Co., Ltd. have in the registry?
The registry currently lists 2 devices for Xiamen Yizhou Imp. & Exp. Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Xiamen Yizhou Imp. & Exp. Co., Ltd.'s devices?
Among its 2 most recently registered devices, Xiamen Yizhou Imp. & Exp. Co., Ltd. has devices listed in EUDAMED (1 device) and FDA 510(k) (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Xiamen Yizhou Imp. & Exp. Co., Ltd.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Xiamen Yizhou Imp. & Exp. Co., Ltd.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Xiamen Yizhou Imp. & Exp. Co., Ltd. in the registry?
The most recently registered devices listed for Xiamen Yizhou Imp. & Exp. Co., Ltd. include Anti Grinding Guard and Mouth Guard.