Jiangsu Trausim Medical Instrument
Active in EUDAMEDChinafrom SRN EUDAMED FDA SRN CN-MF-000006586
- Devices
- 9
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA establishment
What Jiangsu Trausim Medical Instrument makes
Jiangsu Trausim Medical Instrument manufactures the TRAUSIM Dental Implant System, a device designed for dental implant procedures to support osseointegration and restoration of missing teeth.
The TRAUSIM Dental Implant System is classified as a Class II medical device in the US and is listed under the FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
Centrifuge Ref BL4015/111.5926
Regimes: CE IVDR Registry: EUDAMEDImplant Gauge Ref 026.0458
Regimes: CE MDR Registry: EUDAMEDTorque driver Ref 026.0460
Regimes: CE MDR Registry: EUDAMEDDrill Stop Ref 034.0408
Regimes: CE MDR Registry: EUDAMEDCentrifuge Ref DL4015+/111.5992
Regimes: CE IVDR Registry: EUDAMEDCentrifuge Ref DL4015/111.5923
Regimes: CE IVDR Registry: EUDAMEDScrew tap Ref 024.0334
Regimes: CE MDR Registry: EUDAMEDScrewdriver Ref 026.0400
Regimes: CE MDR Registry: EUDAMEDTrausim Dental Implant System Ref K140202
Regimes: 510(k) Registry: 510(k)
Company details
- EUDAMED SRN
- CN-MF-000006586
- EUDAMED status
- Active
- EUDAMED registered name
- Jiangsu Trausim Medical Instrument Co., Ltd.
- EUDAMED abbreviated name
- Trausim
- Registered address
- No.18 Jincheng Road，Wujin Economic Development Zone, 213149, Changzhou City, China
- [email protected]
- PRRC contact
- yu jingbin
FDA establishments
- Jiangsu Trausim Medical Instrument Co., Ltd. Changzhou Jiangsu · CN FEI 3011587077
Frequently asked questions
How many devices does Jiangsu Trausim Medical Instrument have in the registry?
The registry currently lists 9 devices for Jiangsu Trausim Medical Instrument. Devices recorded under merged duplicate company entries are counted once.
Which registries list Jiangsu Trausim Medical Instrument's devices?
Among its 9 most recently registered devices, Jiangsu Trausim Medical Instrument has devices listed in EUDAMED (8 devices) and FDA 510(k) (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Jiangsu Trausim Medical Instrument's devices fall under?
Among its 9 most recently registered devices, the classes recorded for Jiangsu Trausim Medical Instrument's devices are Class I, Class II and IVDR Class A. Each device page shows its own class and authorisation.
What are the newest devices from Jiangsu Trausim Medical Instrument in the registry?
The most recently registered devices listed for Jiangsu Trausim Medical Instrument include Centrifuge, Implant Gauge, Torque driver and Drill Stop.
Which FDA establishments are linked to Jiangsu Trausim Medical Instrument?
1 FDA establishment is linked to Jiangsu Trausim Medical Instrument in the registry; they are listed on the company page.