T&R Biofab Co., Ltd.
Active in EUDAMEDSouth Koreafrom SRN EUDAMED FDA SRN KR-MF-000026617
- Devices
- 2
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA establishment
Catalogue
TnR Cranial Implant Ref K251959
510(k) 510(k)- CE MDD EUDAMED
Company details
- EUDAMED SRN
- KR-MF-000026617
- EUDAMED status
- Active
- EUDAMED registered name
- T&R Biofab Co.,Ltd.
- Registered address
- 96, Mayu-ro, Siheung-si, Gyeonggi-do, Republic of Korea, 15111, Siheung-si, Gyeonggi-do, South Korea
- [email protected]
- PRRC contact
- Daeyang Kim
FDA establishments
- T&R Biofab Co., Ltd Siheung-si Gyeonggi · KR FEI 3016901080
Frequently asked questions
How many devices does T&R Biofab Co.,Ltd. have in the registry?
The registry currently lists 2 devices for T&R Biofab Co.,Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list T&R Biofab Co.,Ltd.'s devices?
Among its 2 most recently registered devices, T&R Biofab Co.,Ltd. has devices listed in EUDAMED (1 device) and FDA 510(k) (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do T&R Biofab Co.,Ltd.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for T&R Biofab Co.,Ltd.'s devices are Class II and Class III. Each device page shows its own class and authorisation.
What are the newest devices from T&R Biofab Co.,Ltd. in the registry?
The most recently registered devices listed for T&R Biofab Co.,Ltd. include TnR Cranial Implant and TnR Mesh.
Which FDA establishments are linked to T&R Biofab Co.,Ltd.?
1 FDA establishment is linked to T&R Biofab Co.,Ltd. in the registry; they are listed on the company page.