Tianjin Kepler Vehicle Industry Co., Ltd
Active in EUDAMEDChinafrom SRN EUDAMED FDA SRN CN-MF-000009029
- Devices
- 8
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA establishment
What Tianjin Kepler Vehicle Industry Co., Ltd makes
Tianjin Kepler Vehicle Industry Co., Ltd manufactures scooters designed for personal mobility, including models intended for urban and recreational use. These devices are primarily battery-powered, lightweight vehicles with three wheels, suitable for short-distance travel and maneuverability in confined spaces.
The company’s scooters fall under Class I medical devices in the EU regulatory framework, as listed in the EUDAMED database. The portfolio is regulated under EU Medical Device Regulations (MDR) or In Vitro Diagnostic Regulation (IVDR) where applicable, though the specific classification may vary by jurisdiction. The manufacturer is based in China.
Catalogue
Scooter Ref KPL00520
Regimes: CE MDR Registry: EUDAMEDScooter Ref KPL00503FG
Regimes: CE MDR Registry: EUDAMEDScooter Ref KPL00121
Regimes: CE MDR Registry: EUDAMEDScooter Ref KPL00150
Regimes: CE MDR Registry: EUDAMEDScooter Ref KPL00503
Regimes: CE MDR Registry: EUDAMEDScooter Ref KPL001
Regimes: CE MDR Registry: EUDAMEDGUDIDScooter Ref KPL00203
Regimes: CE MDR Registry: EUDAMEDScooter Ref KPL00204
Regimes: CE MDR 510(k) Registry: EUDAMED
Company details
- EUDAMED SRN
- CN-MF-000009029
- EUDAMED status
- Active
- EUDAMED registered name
- Tianjin Kepler Vehicle Industry Co.,Ltd
- Registered address
- 9 Xinmin road, west area of economic and technological development zone,, 300462, Tianjin city,, China
- [email protected]
- PRRC contact
- haijun hao
FDA establishments
- Tianjin Kepler Vehicle Industry Co., Ltd. Tianjin · CN FEI 3015726735
Frequently asked questions
How many devices does Tianjin Kepler Vehicle Industry Co.,Ltd have in the registry?
The registry currently lists 8 devices for Tianjin Kepler Vehicle Industry Co.,Ltd. Devices recorded under merged duplicate company entries are counted once.
Which registries list Tianjin Kepler Vehicle Industry Co.,Ltd's devices?
Among its 8 most recently registered devices, Tianjin Kepler Vehicle Industry Co.,Ltd has devices listed in EUDAMED (8 devices) and FDA GUDID (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Tianjin Kepler Vehicle Industry Co.,Ltd's devices fall under?
Among its 8 most recently registered devices, the classes recorded for Tianjin Kepler Vehicle Industry Co.,Ltd's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Tianjin Kepler Vehicle Industry Co.,Ltd in the registry?
The most recently registered devices listed for Tianjin Kepler Vehicle Industry Co.,Ltd include Scooter.
Which FDA establishments are linked to Tianjin Kepler Vehicle Industry Co.,Ltd?
1 FDA establishment is linked to Tianjin Kepler Vehicle Industry Co.,Ltd in the registry; they are listed on the company page.