Xiamen Twe Orthopedics Co., Ltd
Active in EUDAMEDChinafrom SRN EUDAMED FDA SRN CN-MF-000045818 FEI 3029702497
- Devices
- 9
- 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 Twe Orthopedics Co., Ltd makes
The company manufactures external orthopedic supports, including ankle braces, walking boots, knee braces, wrist splints, back braces, cervical collars, hip braces, elbow braces, and shoulder braces. These devices are designed to immobilize, stabilize, or protect joints and limbs during injury recovery or chronic condition management.
The portfolio consists of Class I medical devices, listed in the EU’s eudamed registry. The manufacturer is based in China.
Catalogue
Ankle Brace Ref TA001
CE MDR EUDAMEDWalking Boot Ref TA601
CE MDR EUDAMEDKnee Brace Ref TK001
CE MDR EUDAMEDWrist Splint Ref TW001
CE MDR EUDAMEDBack Brace Ref TB001
CE MDR EUDAMEDCervical Collar Ref TN001
CE MDR EUDAMEDHip Brace Ref TH001
CE MDR EUDAMEDElbow Brace Ref TE001
CE MDR EUDAMEDShoulder Brace Ref TS001
CE MDR EUDAMED
Company details
- EUDAMED SRN
- CN-MF-000045818
- FDA FEI number
- 3029702497
- EUDAMED status
- Active
- EUDAMED registered name
- XIAMEN TWE ORTHOPEDICS CO.,LTD
- Registered address
- 5th Floor, Building 4, No.29 Xinle Road,Haicang District, 361000, Xiamen, Fujian, China
- [email protected]
- PRRC contact
- Huazheng Qiu
Frequently asked questions
How many devices does XIAMEN TWE ORTHOPEDICS CO., LTD have in the registry?
The registry currently lists 9 devices for XIAMEN TWE ORTHOPEDICS CO., LTD. Devices recorded under merged duplicate company entries are counted once.
Which registries list XIAMEN TWE ORTHOPEDICS CO., LTD's devices?
Among its 9 most recently registered devices, XIAMEN TWE ORTHOPEDICS CO., LTD has devices listed in EUDAMED (9 devices).
What risk classes do XIAMEN TWE ORTHOPEDICS CO., LTD's devices fall under?
Among its 9 most recently registered devices, the classes recorded for XIAMEN TWE ORTHOPEDICS CO., LTD's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from XIAMEN TWE ORTHOPEDICS CO., LTD in the registry?
The most recently registered devices listed for XIAMEN TWE ORTHOPEDICS CO., LTD include ANKLE BRACE, WALKING BOOT, KNEE BRACE and WRIST SPLINT.