Ixensor Company, Ltd.
Active in EUDAMEDTaiwanfrom SRN EUDAMED SRN TW-MF-000026279
Part of iXensor Co., Ltd.
- Devices
- 4
- Registrations
- EUDAMED
At a glance
Market reach
- European Union
- EUDAMED actor
What Ixensor Company, Ltd. makes
Ixensor Company, Ltd. manufactures the PixoTest Blood Glucose Monitoring System, a device designed for measuring blood glucose levels in patients.
The PixoTest Blood Glucose Monitoring System is classified as a Class II medical device and is listed under the FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
PixoTest Lipid Test Kit Ref 1636
Regimes: CE IVDD Registry: EUDAMEDEveline Ovulation Test Ref WHM-A01
Regimes: CE IVDD Registry: EUDAMEDPixoTest Blood Glucose Monitoring System Ref K163087
Regimes: 510(k) Registry: 510(k)Eveline Ovulation Test Ref WHM-A01
Regimes: CE IVDD Registry: EUDAMED
Company details
- EUDAMED SRN
- TW-MF-000026279
- EUDAMED status
- Active
- EUDAMED registered name
- iXensor Co., Ltd.
- EUDAMED abbreviated name
- iXensor
- Registered address
- 6F., No.9, Aly. 2, Ln. 35, Jihu Rd., Neihu Dist., 11492, Taipei City, Taiwan
- Website
- www.ixensor.com
- [email protected]
- Phone
- +886 2 8751-1335
- PRRC contact
- Gabriel Chao
Frequently asked questions
How many devices does Ixensor Company, Ltd. have in the registry?
The registry currently lists 4 devices for Ixensor Company, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ixensor Company, Ltd.'s devices?
Among its 4 most recently registered devices, Ixensor Company, Ltd. has devices listed in EUDAMED (3 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 Ixensor Company, Ltd.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Ixensor Company, Ltd.'s devices are Class II, IVD general and IVD devices for self-testing. Each device page shows its own class and authorisation.
What are the newest devices from Ixensor Company, Ltd. in the registry?
The most recently registered devices listed for Ixensor Company, Ltd. include PixoTest Lipid Test Kit, Eveline Ovulation Test and PixoTest Blood Glucose Monitoring System.