Wuhan DYMEX Healthcare Co., Ltd
Active in EUDAMEDChinafrom SRN EUDAMED SRN CN-MF-000008966
- Devices
- 9
- Registrations
- EUDAMED
At a glance
Market reach
- European Union
- EUDAMED actor
- Authorised rep.
- SUNGO Europe B.V.NL
What Wuhan DYMEX Healthcare Co., Ltd makes
Wuhan DYMEX Healthcare Co., Ltd produces single-use protective apparel and respiratory barriers, including disposable gowns, medical nonwoven coveralls, surgical isolation cover gowns, and surgical gowns. Their portfolio also includes disposable shoe covers, as well as surgical and medical face masks with ear loops and tie-on designs.
The company’s products are classified under EU Class I and Class II devices and are listed in the EUDAMED database and the FDA’s 510(k) registry. The manufacturer is based in China.
Catalogue
Disposable Gown Ref 120*140
Regimes: CE MDR Registry: EUDAMED- Regimes: CE MDR Registry: EUDAMED
Medical face mask Ref 17.5*9.5cm
Regimes: CE MDR Registry: EUDAMEDSurgical Face Mask (Ear loops and Tie-on) Ref K210433
Regimes: 510(k) Registry: 510(k)Surgical Face Mask Ref K182515
Regimes: 510(k) Registry: 510(k)Surgical Isolation Cover Gown Ref K220528
Regimes: 510(k) Registry: 510(k)Surgical Gown Ref K211809
Regimes: 510(k) Registry: 510(k)- Regimes: CE MDR Registry: EUDAMED
Disposable Shoe Cover Ref Universal
Regimes: CE MDR Registry: EUDAMED
Company details
- EUDAMED SRN
- CN-MF-000008966
- EUDAMED status
- Active
- EUDAMED registered name
- Wuhan DYMEX Healthcare Co.,Ltd
- Registered address
- 1701, Unit 2, Building 5, Jinsegangwan Phase 5, Dongfeng Avenue, 430000, Wuhan, Hubei, China
- [email protected]
- PRRC contact
- Bill LIAO
Frequently asked questions
How many devices does Wuhan DYMEX Healthcare Co., Ltd have in the registry?
The registry currently lists 9 devices for Wuhan DYMEX Healthcare Co., Ltd. Devices recorded under merged duplicate company entries are counted once.
Which registries list Wuhan DYMEX Healthcare Co., Ltd's devices?
Among its 9 most recently registered devices, Wuhan DYMEX Healthcare Co., Ltd has devices listed in EUDAMED (5 devices) and FDA 510(k) (4 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Wuhan DYMEX Healthcare Co., Ltd's devices fall under?
Among its 9 most recently registered devices, the classes recorded for Wuhan DYMEX Healthcare 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 Wuhan DYMEX Healthcare Co., Ltd in the registry?
The most recently registered devices listed for Wuhan DYMEX Healthcare Co., Ltd include Disposable Gown, Medical nonwoven coverall, Medical face mask and Surgical Face Mask (Ear loops and Tie-on).