iWEECARE Co., Ltd.
Active in EUDAMEDTaiwanfrom SRN EUDAMED SRN TW-MF-000045851
- Devices
- 3
- Registrations
- EUDAMED
At a glance
Market reach
- European Union
- EUDAMED actor
- Authorised rep.
- Obelis S.A.BE
Catalogue
- Regimes: 510(k) Registry: 510(k)
Temp Pal Ref K202603
Regimes: 510(k) Registry: 510(k)CuboAi Smart Temp Ref STP-MB01-1
Regimes: CE MDD Registry: EUDAMEDGUDID
Company details
- EUDAMED SRN
- TW-MF-000045851
- DUNS number
- 658869653
- EU VAT number
- 54686801
- EUDAMED status
- Active
- EUDAMED registered name
- iWEECARE Co., Ltd.
- EUDAMED abbreviated name
- iWEECARE
- Registered address
- Sec. 5, Xinyi Rd., Xinyi Dist., 110416, Taipei City, Taiwan
- [email protected]
- PRRC contact
- Felix Cheng
Frequently asked questions
How many devices does iWEECARE Co., Ltd. have in the registry?
The registry currently lists 3 devices for iWEECARE Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list iWEECARE Co., Ltd.'s devices?
Among its 3 most recently registered devices, iWEECARE Co., Ltd. has devices listed in EUDAMED (1 device), FDA 510(k) (2 devices) and FDA GUDID (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do iWEECARE Co., Ltd.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for iWEECARE Co., Ltd.'s devices are Class IIa and Class II. Each device page shows its own class and authorisation.
What are the newest devices from iWEECARE Co., Ltd. in the registry?
The most recently registered devices listed for iWEECARE Co., Ltd. include Temp Pal (Smart Thermometer Patch) Model Number: STP-MB01-1, Temp Pal and CuboAi Smart Temp.